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Borderline Personality Disorder

Borderline personality disorder is a mental illness that severely impacts a person’s ability to regulate their emotions. This loss of emotional control can increase impulsivity, affect how a person feels about themselves, and negatively impact their relationships with others. Learn more about borderline personality disorder.

Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.


Neurostimulation Versus Therapy for Problems With Emotions

Study Type: Interventional
Start Date: May 15, 2023
Eligibility: 18 Years to 55 Years, Does Not Accept Healthy Volunteers
Location(s): Duke University Medical Center, Durham, North Carolina, United States

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training.

Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.


Suicide Prevention for Sexual and Gender Minority Youth (Randomized Controlled Trial)

Study Type: Interventional
Start Date: April 10, 2023
Eligibility: 15 Years to 29 Years, Accepts Healthy Volunteers
Location(s): San Diego State University, San Diego, California, United States

The overarching goal of this study is to evaluate a newly-developed suicide prevention program for sexual and gender minority youth and emerging adults. After development of the intervention program, a randomized controlled trial will be conducted to test its preliminary efficacy in lowering the risk for suicide attempts.


Brief Suicide Intervention for Youth in Juvenile Detention Settings

Study Type: Interventional
Start Date: March 15, 2023
Eligibility: 13 Years to 17 Years, Accepts Healthy Volunteers
Location(s): Duke University, Durham, North Carolina, United States; Wake Forest School of Medicine, Winston-Salem, North Carolina, United States

This is an intervention development study and therefore is not designed or powered to test hypotheses. Following initial development and refinement of intervention and protocol, an open trial will be conducted at one juvenile detention facility (n=20). Following further refinement, six juvenile detention sites will be randomized to first or second wave of intervention implementation. All youth at an implementation site in suicidal crises will receive the intervention. Data will only be collected from youth with prior assent/consent. Youth will be assessed at the time of the suicidal/self-harm crisis, just prior to release from the juvenile detention facility, and at a two-month follow-up assessment. We will preliminarily examine feasibility of the intervention and associated patterns of suicidal thoughts and behavior and non-suicidal self-injury, linkage to care following release, and presumed mechanisms of change such as hopelessness, self-efficacy to remain safe, urgency to act on suicidal thoughts, and acceptance.


Clinical Trial for Integrated Care to Help At Risk Teen (iCHART) Intervention

Study Type: Interventional
Start Date: January 26, 2023
Eligibility: 12 Years to 18 Years, Does Not Accept Healthy Volunteers
Location(s): Children's Community Pediatrics (CCP- Waterdam) of Children's Hospital of Pittsburgh UPMC, McMurray, Pennsylvania, United States; UPMC Center for Adolescent and Young Adult Health, Pittsburgh, Pennsylvania, United States

This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cybervictimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.


Zero Suicide Implementation in Outpatient Mental Health Clinics (R56)

Study Type: Interventional
Start Date: November 20, 2022
Eligibility: 18 Years to 64 Years, Does Not Accept Healthy Volunteers
Location(s): New York State Psychiatric Institute, New York, New York, United States

The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal.

This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care.

In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.


Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care

Study Type: Interventional
Start Date: November 7, 2022
Eligibility: 13 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): University of Michigan's (Child and Adolescent Psychiatric Inpatient Program), Ann Arbor, Michigan, United States

This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.


Comprehensive Adaptive Multisite Prevention of University Student Suicide

Study Type: Interventional
Start Date: October 25, 2022
Eligibility: 18 Years to 25 Years, Does Not Accept Healthy Volunteers
Location(s): University of Oregon, Eugene, Oregon, United States; Rutgers University, New Brunswick, New Jersey, United States; Duke University, Durham, North Carolina, United States; University of Nevada - Reno, Reno, Nevada, United States

Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance.

The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center

This multisite study will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.


Suicide Prevention Intervention for Vulnerable Emerging Adult Sexual Minorities

Study Type: Interventional
Start Date: October 20, 2022
Eligibility: 18 Years to 24 Years, Does Not Accept Healthy Volunteers
Location(s): University of Pennsylvania, Center for the Treatment and Study of Anxiety, Philadelphia, Pennsylvania, United States

Emerging adult sexual minorities (EASM) are vulnerable to stressors that increase risk for suicidal ideation and behaviors. The investigators will examine a mobile application that leverages skills coaching and peer mentoring to reduce suicide risk for EASM. The online life skills intervention (iREACH) was developed to reduce a variety of negative health outcomes using telehealth with peer mentors. In Supporting Transitions to Adulthood and Reducing Suicide (STARS), investigators' interdisciplinary team will adapt iREACH to reduce suicidal ideation and behaviors among EASM. Then, investigators will pilot test STARS using in a racially/ethnically diverse sample of EASM with suicidal ideation. Participants will be randomized to receive an in-person brief, evidence-based safety planning protocol or to receive safety planning plus access to STARS. This project will identify the potential clinical utility of STARS for suicide prevention in a vulnerable, marginalized, population to inform a future larger efficacy RCT.


Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

Study Type: Interventional
Start Date: October 3, 2022
Eligibility: 13 Years to 18 Years, Does Not Accept Healthy Volunteers
Location(s): UT Southwestern Medical Center, Dallas, Texas, United States

This project aims to examine the efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.

The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.


Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

Study Type: Interventional
Start Date: October 1, 2022
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Palo Alto University, Palo Alto, California, United States

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth.

Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.


Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

Study Type: Interventional
Start Date: October 1, 2022
Eligibility: 10 Years to 24 Years, Accepts Healthy Volunteers
Location(s): UAB Huntsville Regional Medical Campus, Huntsville, Alabama, United States; University of Alabama at Birmingham, Birmingham, Alabama, United States

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.


Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Study Type: Interventional
Start Date: September 1, 2022
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): University of Michigan, Ann Arbor, Michigan, United States

Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (T4) with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group (n=10). Providers (n=12) will be trained to deliver CBSPp and be assessed from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.


Ketamine Treatment of Youth Suicide Attempters

Study Type: Interventional
Start Date: June 27, 2022
Eligibility: 14 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): The Cleveland Clinic, Cleveland, Ohio, United States; Massachusetts General Hospital, Boston, Massachusetts, United States

Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 15-24. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 140 youth between the ages 15- 24 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until, as an outpatient, they have a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, for at least 3 consecutive sessions of CAMS.


Culture and Well-Being for Latinos

Study Type: Interventional
Start Date: June 1, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Rochester Medical Center, Rochester, New York, United States

The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.


Mental Health in Primary Care

Study Type: Interventional
Start Date: April 26, 2022
Eligibility: 12 Years to 16 Years, Accepts Healthy Volunteers
Location(s): Pediatric Mobile Clinic, Miami, Florida, United States; University of Miami UHealth Pediatrics at Kendall, Miami, Florida, United States; UHealth Pediatrics at Kendall, Miami, Florida, United States; Belkys Bravo Clinic, Miami, Florida, United States; Borinquean Medical Centers, Miami, Florida, United States; UM UHealth Pediatrics at the Professional Arts Center, Miami, Florida, United States; UM Pediatric Mobile Clinic, Miami, Florida, United States; Mailman for Child Devlopment, Miami, Florida, United States

The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.


WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt

Study Type: Interventional
Start Date: April 22, 2022
Eligibility: 50 Years to 90 Years, Does Not Accept Healthy Volunteers
Location(s): Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, New York, United States

The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).


Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students

Study Type: Interventional
Start Date: April 6, 2022
Eligibility: 21 Years and Older, Accepts Healthy Volunteers
Location(s): Ponce Health Sciences University, Ponce, Puerto Rico

The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.


Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Study Type: Interventional
Start Date: April 4, 2022
Eligibility: 12 Years to 18 Years, Does Not Accept Healthy Volunteers
Location(s): Mayo Clinic in Rochester, Rochester, Minnesota, United States

The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.


Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder

Study Type: Interventional
Start Date: March 1, 2022
Eligibility: 21 Years to 55 Years, Does Not Accept Healthy Volunteers
Location(s): New York State Psychiatric Institute, New York, New York, United States

The purpose of this research study is to test how a medication called nabilone (Cesamet) affects neurocognitive processes involved in obsessive-compulsive disorder (OCD), including threat response, processing of fear signals, and habitual behavior. OCD is a disabling illness that affects around 2% of the population and involves recurrent intrusive thoughts (obsessions) and repetitive behaviors (compulsions) that lead to distress and/or impaired functioning. Nabilone is a synthetic form of delta-9-tetrahydrocannabinol (THC, the primary psychoactive component of the cannabis plant). It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD symptoms. Nabilone is approved by the FDA for the treatment of chemotherapy-induced nausea and vomiting. It is not FDA-approved for treating OCD.

In this study, 60 adults with OCD will receive a single dose of either nabilone or placebo. Participants will then complete a series of assessments including neuroimaging, psychophysiology (e.g., skin conductance recording), computerized behavioral tasks, and self-report measures. The information gained from this study could contribute to the development of new treatments for people with OCD and related disorders.


Preventing Suicide in African American Adolescents

Study Type: Interventional
Start Date: February 1, 2022
Eligibility: 12 Years and Older, Accepts Healthy Volunteers
Location(s): Dunbar Vocational Career Academy, Chicago, Illinois, United States; Orr Academy High School, Chicago, Illinois, United States; Richard T. Crane High School, Chicago, Illinois, United States

The overarching aim of the Success Over Stress Prevention Project is to reduce African American youth suicide. This study examines the impact of a 15-session, group-delivered, culturally-grounded, cognitive-behavioral intervention (i.e., PI Robinson's Adapted-Coping with Stress Course [A-CWS]), on the outcomes of interest, when it is delivered by social workers who are indigenous to the school system. The main objectives of this project are to (a) determine whether the intervention is effective when facilitated by social workers who are indigenous to the school system and (b) enhance resilience, increase adaptive coping strategies, and reduce both intrapersonal and interpersonal violence among youth receiving the prevention intervention. It is expected that increases in adaptive coping will lead to an increased ability for youth to manage stressors, thereby decreasing the incidence of suicide and violence among the youth. In addition, it is expected that evidence of the intervention's effectiveness, when facilitated by social workers who are indigenous to the school system, will lead to greater dissemination and sustainability of the intervention, thus, providing access to effective intervention resources to greater numbers of African American youth.


Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine

Study Type: Interventional
Start Date: January 21, 2022
Eligibility: 13 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): Yale New Haven Hospital, New Haven, Connecticut, United States

The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo (midazolam) in adolescents who have treatment resistant depression and a recent history of a suicide event (defined as a suicide attempt, emergency room evaluation for suicidal thinking, or a transition to inpatient care for suicidality in the past 120 days).

The primary objective of this study is to determine whether ketamine reduces suicidal ideation (as measured via the C-SSRS, recent ideation scale) relative to an active control, midazolam, 48-hours after first administration in adolescents with TRD at high suicide risk.


Cognitive Reappraisal Training for Borderline Personality

Study Type: Interventional
Start Date: December 1, 2021
Eligibility: 18 Years to 55 Years, Does Not Accept Healthy Volunteers
Location(s): Icahn School of Medicine at Mount Sinai, New York, New York, United States

Previous work by the study group convinced the study team to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. The present proposal aims to refine and test a proposed clinical intervention for BPD patients, training in reappraisal-by-distancing, in terms of its ability to influence hypothesized neural and behavioral targets and, once that is established, to demonstrate its ability improve clinically relevant outcome measures.


Long-term Observation of Participants With Mood Disorders

Study Type: Observational
Start Date: August 17, 2021
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

More than 12,000 people have taken part in research at the Experimental Therapeutics & Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments.

Objective:

To learn the long-term impact of depression, bipolar disorder, and suicide risk.

Eligibility:

Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago.

Design:

This study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact.

In Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview.

In Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH.

In both phases, participants can skip any questions they do not want to answer.

The online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours.

The information that participants give in this study may be linked to their other NIH research records.


Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Study Type: Interventional
Start Date: August 13, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Mount Sinai West, New York, New York, United States

Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically significant response to ALIC DBS. However, ALIC DBS may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient. This study therefore investigates personalized stimulation to the ALIC that allows for precise modulation of brain circuits associated with individual OCD symptoms. The study aims to specify the ideal anatomical target for ALIC DBS for maximum therapeutic benefit in each patient.


Ask Suicide-Screening Questions (ASQ) for Youth With Autism Spectrum and Neurodevelopmental Disorders

Study Type: Observational
Start Date: July 15, 2021
Eligibility: 8 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): Kennedy Krieger Institute/Johns Hopkins University, Baltimore, Maryland, United States; National Institutes of Health Clinical Center, Bethesda, Maryland, United States; Nationwide Children's Hospital/ Ohio State University, Columbus, Ohio, United States

Background:

Suicide is the second leading cause of death for young people ages 10-24 years. There is no gold standard for evaluating suicidal thoughts and behaviors in young people with autism spectrum disorder (ASD) or other neurodevelopmental disorders (NDD). Also, youth with ASD/NDD are often excluded from many research studies. Because of this, researchers need more data. They want to make sure they are asking the best questions for young people in clinics such as the National Institute of Mental Health (NIMH) clinic. They want to make sure they have the best data to determine if a person is at risk for hurting or killing himself or herself.

Objective:

To develop and assess the efficacy of a suicide screening tool for people with ASD/NDD.

Eligibility:

Youth ages 8 to 17 who are engaged in assessment or treatment at the NIMH for ASD or other NDD

Design:

Participants will fill out 4 questionnaires during a 1-hour meeting with study staff. They will answer questions about how they have been feeling. They will be asked if they think about or plan to hurt or kill themselves. They will also be asked if they have ever thought about it or planned it in the past. Other questions will assess their understanding of death. Participants can take a break if needed.

Parents of the participants will be asked similar questions.

Parents will be informed if their child has current thoughts of suicide.

About 1 week after the initial assessment, parents will be contacted to fill out a follow-up questionnaire. It will take about 10 minutes to complete.


Telehealth to Improve Prevention of Suicide (TIPS)

Study Type: Interventional
Start Date: July 12, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): UMass Chan Medical School, Worcester, Massachusetts, United States

The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.


Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention

Study Type: Interventional
Start Date: March 5, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Yale University, New Haven, Connecticut, United States; Emory University, Atlanta, Georgia, United States; UAB Medicine | Heersink School of Medicine, Birmingham, Alabama, United States

This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine.


MicroRNA Correlates of Childhood Maltreatment and Suicidality

Study Type: Observational
Start Date: February 26, 2021
Eligibility: 18 Years to 60 Years, Accepts Healthy Volunteers
Location(s): University of Alabama at Birmingham, Birmingham, Alabama, United States; UAB Huntsville Regional Medical Campus, Huntsville, Alabama, United States

This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.


IM Ketamine vs Midazolam for Suicidal ER Patients

Study Type: Interventional
Start Date: January 2, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Comprehensive Psychiatric Emergency Department of Columbia University Medical Center, New York, New York, United States

Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.


Suicide in Urban Natives: Detection and Networks to Combat Events

Study Type: Interventional
Start Date: March 15, 2020
Eligibility: 18 Years to 34 Years, Does Not Accept Healthy Volunteers
Location(s): First Nations Community HealthSource, Albuquerque, New Mexico, United States

This study compares the effectiveness of a program to detect and manage suicide risk among American-Indian and Alaska Native (AI/AN) youth. Half of the participants will receive caring text messages to reduce suicidal thoughts, attempts, and hospitalizations and to increase engagement, social connectedness, and resilience in at-risk youth. The other half will receive usual care that does not include the caring text messages.


Engaging Black Youth in Depression and Suicide Prevention Treatment Within Urban Schools

Study Type: Interventional
Start Date: January 31, 2020
Eligibility: 12 Years to 18 Years, Accepts Healthy Volunteers
Location(s): McSilver Institute for Poverty Policy and Research, New York, New York, United States

Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products.

This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.


Wakȟáŋyeža (Little Holy One)

Study Type: Interventional
Start Date: November 18, 2019
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Fort Peck Tribal Head Start, Poplar, Montana, United States

The overall goal of this study is to develop, adapt and evaluate an intergenerational prevention intervention, named "Wakȟáŋyeža (Little Holy One)," with Native American caregivers on a Northern Plains reservation and the caregivers' 3-to-5-year-old children. The intervention aims to: 1) reduce symptoms of historical trauma and everyday stress among parents/caregivers, 2) improve parenting, and 3) improve children's emotional and behavioral developmental outcomes to reduce future risk for suicide and substance use.


A Longitudinal Study of Inflammatory Pathways in Depression

Study Type: Observational
Start Date: October 1, 2019
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Pine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States

Suicide accounts for at least 1 million deaths globally each year. This is likely a significant underestimate, because suicide is under-reported in many countries. In the US, over 42,000 people die from suicide annually. Despite increased focus on identification and treatment, the rate of suicide has increased steadily over the past 15 years.

Our project aims both to improve our understanding of factors that increase the risk for suicide by comparing blood biomarkers associated with inflammation in patients with depression without suicidal behavior and patients with depression and suicidal behavior. The 160 individuals in this study will be followed with psychiatric assessments and blood samples at repeated time points over one year.


e-Connect: A Service System Intervention for Justice Youth at Risk for Suicide

Study Type: Interventional
Start Date: August 1, 2019
Eligibility: 10 Years and Older, Accepts Healthy Volunteers
Location(s): New York State Psychiatric Institute, New York, New York, United States

The investigators propose to create e-Connect: a new service delivery model that will enable real time identification and targeted, county-specific referral and linkage of participants with suicidal behavior (SB) and related behavioral health (BH) problems. e-Connect will: (i) establish and formalize interagency referral decisions based on clinical need, jointly derived by JJ (juvenile justice) and BH agencies; (ii) train probation staff to increase BH/SB understanding; (iii) utilize an existing evidence-based (EB) BH/SB screen; and (iv) develop a mobile application to seamlessly integrate screening, classification of clinical need and development of a related referral plan. There are 4 project phases: Development, Baseline, Implementation, and Sustainment/Evaluation. After development, activities take place in 10 NY (New York) counties and all study counties will begin the intervention at the same time. The investigators will examine changes in outcomes (e.g., service use) relative to baseline in (i) identification of participants service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) participants BH service use (access and engagement). Analyses will further consider contributions of multi-level factors (e.g., staff, organizational, family, and community) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases). The investigators will consider the role of mediating elements (e.g., probation practices) in explaining the association between e-Connect and identification, referral, and service use.


Wearable Suicidal Early Warning System for Adolescents

Study Type: Observational
Start Date: September 18, 2017
Eligibility: 13 Years to 19 Years
Location(s): OHSU, Portland, Oregon, United States

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.


A Novel Cognitive Reappraisal Intervention for Suicide Prevention

Study Type: Interventional
Start Date: March 28, 2017
Eligibility: 50 Years to 90 Years, Does Not Accept Healthy Volunteers
Location(s): Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine, White Plains, New York, United States

The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).


Neurobiology of Suicide

Study Type: Interventional
Start Date: December 1, 2015
Eligibility: 18 Years to 70 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.

Objective:

To understand what happens in the brain when someone has thought about or attempted suicide.

Eligibility:

Group 1: Adults ages 18 70 who have thought about or attempted suicide recently

Group 2: Adults ages 18 70 who have thought about or attempted suicide in the past

Group 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide

Group 4: Healthy volunteers the same ages.

Design:

Participants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.

Phase 1: 1 week in hospital. Participants will have:

Physical exam.

Questions about thoughts and feelings.

Thinking and memory tests and simple tasks.

Blood and urine tests.

Two MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.

Sleep test. Disks and bands will be placed on the body to monitor it during sleep.

Magnetic detectors on their head while they perform tasks.

A wrist monitor for activity and sleep.

Lumbar puncture (optional). A needle will collect fluid from the back.

Shock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.

Phase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.

Phase 3: up to 4 more ketamine doses over 2 weeks.

Participants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.


Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships

Study Type: Interventional
Start Date: March 31, 2008
Eligibility: Females, 18 Years to 64 Years, Does Not Accept Healthy Volunteers
Location(s): Grady Hospital, Atlanta, Georgia, United States

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.