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Bipolar Disorder

Bipolar disorder, formerly called manic-depressive illness, is a mood disorder that causes unusual shifts in a person’s mood, energy, activity levels, concentration, and ability to carry out day-to-day tasks. The mood shifts in bipolar disorder are different from normal ups and downs — they include periods of extremely “up,” elated, irritable, or energized behavior (known as manic episodes) and very “down,” sad, indifferent, or hopeless periods (known as depressive episodes). Learn more about bipolar disorder.

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For opportunities to participate in NIMH research on the NIH campus, visit the clinical research website. Travel and lodging assistance may be available.

Featured Studies

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

Project CARE: An Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release - Pilot RCT

Study Type: Interventional
Start Date: January 21, 2020
Locations: Cranston, Rhode Island; Providence, Rhode Island
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

The aim of this program of research is to develop and pilot the CARE (Community treatment Adherence at Re-Entry) program, an adjunctive intervention for incarcerated individuals with bipolar disorder (BD) transitioning from prison to the community.

The purpose of this proposed project is to establish the feasibility, acceptability, and preliminary effects of this newly developed intervention on symptom outcomes in a small pilot randomized controlled feasibility trial.

Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis

Study Type: Interventional
Start Date: January 16, 2020
Location: Ann Arbor, Michigan
Eligibility: Ages 16–60, Accepts Healthy Volunteers

The purpose of this study is to better understand mental illness and will test the hypotheses that while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam.

This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as schizophrenia, bipolar disorder, and schizoaffective disorder). The study will also enroll eligible participants without any psychiatric illness, to compare their brains.

The study will require participants to have 3-4 sessions over a few weeks. The first session (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.

Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3

Study Type: Interventional
Start Date: September 13, 2019
Location: Ann Arbor, Michigan
Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

This study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. Its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective and evidence-based adaptive intervention. In this aim of the study, investigators will evaluate how individuals with BP respond to a microintervention based in acceptance and commitment therapy (ACT) that is delivered with a mobile app.

The Police-Mental Health Linkage System

Study Type: Interventional
Start Date: February 6, 2019
Locations: Decatur, Georgia; Savannah, Georgia
Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

The aim of this randomized, controlled trial is to study the effectiveness of a potential new form of pre-arrest jail diversion for people with serious mental illnesses: the Police-Mental Health Linkage System. In the case of an encounter with a police officer, for half of the participants, during the background check, a message will notify the officer that the subject has mental health considerations. The notice contains a phone number of a provider working at the mental health clinic where the subject is receiving services, who can provide telephonic support to the officer. For the other half of participants, the message will not appear to the officers in the case of an encounter.

Technology Enhanced Family Treatment

Study Type: Interventional
Start Date: November 15, 2018
Location: Los Angeles, California
Eligibility: Ages 13–19, Does Not Accept Healthy Volunteers

The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). In adolescents with mood instability who have a parent with bipolar or major depressive disorder, clinicians in community clinics will conduct FFT sessions (consisting of psychoeducation and family skills training) supplemented by weekly MCC "real time" assessments of moods and family relationships; based on results of these assessments and the family's progress in treatment, clinicians will then push personalized informational and coaching alerts regarding the practice of communication and problem-solving skills. The investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective than FFT without coaching/informational alerts in altering treatment targets and in stabilizing youths' mood symptoms and quality of life.

Magnetic Resonance Spectroscopy (MRS) in Midlife Depression

Study Type: Observational
Start Date: July 31, 2016
Location: Atlanta, Georgia
Eligibility: Ages 35–65, Accepts Healthy Volunteers

The purpose of this study is to determine the impact of inflammation on central nervous system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in middle-aged patients with major depression. Depression is associated with significant alterations in glutamate concentrations and white matter integrity, which has been associated with decreased antidepressant response, poor functional outcome, and cognitive impairment.

Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth

Study Type: Interventional
Start Date: December 31, 2015
Locations: Stanford, California; Cincinnati, Ohio
Eligibility: Ages 12–17, Accepts Healthy Volunteers

A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a MRI scan and then randomized to treatment. Following randomization, high-risk youth will have visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.

Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder

Study Type: Interventional
Start Date: November 30, 2015
Location: Cincinnati, Ohio
Eligibility: Ages 10–18, Accepts Healthy Volunteers

The main purpose of this study is to see the affects of the study medication called mixed amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The researchers also want to see if MAS-XR makes your child more or less likely to develop problems like acting out (i.e. periods of irritability, agitation, aggression).

MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention deficit hyperactivity disorder (ADHD) in adults, children and adolescents.

Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder

Study Type: Interventional
Start Date: February 28, 2014
Location: Pittsburgh, Pennsylvania
Eligibility: Ages 12–18, Does Not Accept Healthy Volunteers

Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.

Family Study of Affective and Anxiety Spectrum Disorders

Study Type: Observational
Start Date: May 21, 2004
Location: Bethesda, Maryland
Eligibility: Ages N/A–60, Accepts Healthy Volunteers

This study will examine how depression, anxiety, and migraine run in families. It will help in defining the risk factors for physical, mental, and health problems-as well as define ways that those problems may be prevented and treated.

A broad range of ages among family members will be included to evaluate the patterns of how these disorders are expressed throughout people's lives. Children of all ages will be included, and those ages 8 to 17 will be interviewed directly.

Assessments will be collected through criteria of the Diagnostic and Statistical Manual of Mental Disorders IV as well as the spectrum, or range, of mood disorders and co-existing conditions. A member of the study team will visit the participants at home or will do an interview by telephone. Participation will take approximately 3 to 4 hours. Children will complete questionnaires given by the research team as well as questionnaires that they will do by themselves. The questions will pertain to the children's health, including physical and mental health and medical history, social relationships, problems, skills, and ways of dealing with important or stressful issues in their lives. These questionnaires will take up to 1 hour to complete.

Health history gathered from adult participants will pertain to height, weight, exercise, and general function. Women will be asked about the use of oral contraceptives, estrogen, and progesterone. In addition, there will be questionnaires on personality and temperamental traits, that is, behavior and impulsiveness. Questions will also involve social intuition, family and other environmental factors, general functioning, and basic demographics such as ethnicity, race, socioeconomic status, marital status, education level, and employment history.

Families enrolled in this phase of the research will be invited to participate in the next phase. There would be follow-up to evaluate the development of mood disorders, subtypes, and syndromes across the lifespan.

Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

Study Type: Observational
Start Date: December 9, 1997
Location: Bethesda, Maryland
Eligibility: Ages 3–99, Accepts Healthy Volunteers

The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.

Evaluation of the Genetics of Bipolar Disorder

Study Type: Observational
Start Date: August 4, 1980
Location: Bethesda, Maryland
Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

This study looks to identify genes that may affect a person's chances of developing bipolar disorder (BP) and related conditions.