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Studies Recruiting Only Women

Mental illnesses affect women and men differently — some disorders are more common in women, and some express themselves with different symptoms. Learn more about Women and Mental Health.

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Featured Studies

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

Adolescent Attention to Emotion Study

Study Type: Interventional
Start Date: October 31, 2019
Location: Pittsburgh, Pennsylvania
Eligibility: Females, Ages 13–15, Accepts Healthy Volunteers

Rates of depression increase rapidly during adolescence, especially for girls, and, thus, research is needed to spur the development of novel interventions to prevent adolescent depression. This project seeks to determine if a novel visuocortical probe of affect-biased attention (i.e., steady-state visual evoked potentials derived from EEG) can 1) be used to prospectively predict depression using a multi-wave repeated measures design and 2) modify affect-biased attention and buffer subsequent mood reactivity using real time neurofeedback. This work could ultimately lead to improved identification of adolescents who are at high risk for depression and directly inform the development of mechanistic treatment targets to be used in personalized intervention prescriptions for high-risk youth.

Integrating PrEP Into Family Planning Services at Title X Clinics in the Southeastern US

Study Type: Observational
Start Date: October 7, 2019
Location: Atlanta, Georgia
Eligibility: Females, Ages 13–45, Accepts Healthy Volunteers

Pre-exposure Prophylaxis (PrEP) is a daily pill to prevent HIV that, when taken as prescribed, reduces the risk of getting HIV from sexual intercourse or drug use. In the United States, most studies which examine prescribing PrEP have not included young women. PrEP provides a way for women to take control of their HIV prevention and may be a good option for some women.

Family planning clinics are a trusted source of preventative, routine, and symptom-driven gynecological care for adolescent and young adult women (AYAW). Thus, these clinics are a natural setting to provide PrEP services for AYAW. This study will examine how effectively three clinics in Atlanta are able to implement a PrEP program for their eligible female patients as well as follow a cohort of 300 women for six months (150 starting PrEP immediately and 150 electing to not take PrEP, at least initially) to characterize individual, provider, and clinic-level variables and constructs that are associated with PrEP uptake, continuation, and adherence.

Both participant and biological data will be collected to answer the primary research question. Women will provide blood, urine, oral, vaginal, anal, and hair samples at three different time points. These samples will be tested to measure incident sexually transmitted infections and unplanned pregnancies as well as PrEP adherence (for women who initiated PrEP). Ultimately, this data will describe each clinic's effectiveness at providing PrEP services to AYAW.

Effects of an ER Beta Agonist (Lilly Compound LY500307) on Estradiol-Withdrawal-Induced Mood Symptoms in Women With Past Perimenopausal Depression

Study Type: Interventional
Start Date: May 23, 2019
Location: Bethesda, Maryland
Eligibility: Females, Ages 45–65, Does Not Accept Healthy Volunteers

Background:

Some women who had depression in the perimenopause may have mood symptoms again if they stop estrogen therapy. Estrogen acts in the brain and other tissues by binding to at least three types of estrogen receptors. One of these receptors, estrogen receptor beta may affect anxiety and depression. The drug LY500307 acts only on this receptor. In this study, researchers will initially give you estrogen and then suddenly stop estrogen after three weeks. Then they will study how LY500307 affects mood symptoms.

Objectives:

To study how withdrawing estradiol affects mood. To test the safety and side effects of LY500307.

Eligibility:

Healthy women ages 45-65 who had depression related to perimenopause in recent years and whose mood systems got better with estradiol

Design:

-Participants will be screened with:

Medical history

Physical exam

Blood tests

Psychiatric interview

Gynecological exam

- Participants able to get pregnant must use effective barrier birth control throughout the study.

- During the first 3 weeks, participants will wear an estrogen patch. It is 1x2 inches and will be replaced every 3 days.

- For the next 3 weeks, participants will take 3 study capsules every morning. They will not know if they get the study drug or placebo.

- Some participants will also take a progesterone-like drug for 1 week at the end of the medication phase of the study.

- Participants will have 9 one-hour study visits. They will have blood samples and vital signs taken. They will answer questions about mood and behavior symptoms.

- Participants will keep a daily log of these symptoms.

- Participants will have 2 transvaginal ultrasounds. A probe is temporarily placed 2-3 inches into the vaginal canal and sound waves are used to create pictures of the lining of the uturus.

- Participants will have a final visit 4 weeks after stopping the study drug. They will answer questions about mood and side effects.

The PrEP (Pre-exposure Prophylaxis) SMART Study

Study Type: Interventional
Start Date: May 16, 2019
Location: Johannesburg, South Africa
Eligibility: Females, Ages 18–25, Accepts Healthy Volunteers

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.

The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms

Study Type: Interventional
Start Date: October 26, 2018
Location: East London, Eastern Cape, South Africa
Eligibility: Females, Ages 16–25, Accepts Healthy Volunteers

The investigators aim to 1) speed up access to and delivery of PrEP to young women, and 2) compare interventions to support and maximize the prevention-effective use of PrEP. Specifically, the investigators aim to answer the following two questions: 1) how can the study use existing community-based platforms to identify and deliver PrEP to those in need? and 2) which adherence support interventions are most likely to engender effective use of PrEP? The investigators propose to answer these questions by leveraging existing community-based HIV testing platforms in South Africa and use a mixed methods approach to optimize the PrEP cascade and evaluate a community-based PrEP adherence program for young women.

VITAL Start: Brief Facility-based Video Intervention

Study Type: Interventional
Start Date: October 1, 2018
Location: Lilongwe, Malawi
Eligibility: Females, Ages 16 and Older, Accepts Healthy Volunteers

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

Efficacy Trial of a Dissonance Based Eating Disorder Program

Study Type: Interventional
Start Date: August 15, 2018
Location: Mount Vernon, Iowa
Eligibility: Females, Ages 15–34, Does Not Accept Healthy Volunteers

The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.

Project EQuIP: Empowering Queer Identities in Psychotherapy

Study Type: Interventional
Start Date: July 18, 2018
Location: New York, New York
Eligibility: Females, Ages 18–35, Does Not Accept Healthy Volunteers

The aim of this study is to develop an evidence-based psychosocial intervention for sexual minority women. This intervention will specifically target the adverse mental and behavioral health outcomes disproportionately experienced by sexual minority women, including depression, suicidality, and alcohol abuse, which are known to be driven by stigma-related stressors associated with their sexual orientation (i.e., minority stress processes).

Ovarian Hormones and Suicide Risk

Study Type: Interventional
Start Date: April 15, 2018
Location: Chicago, Illinois
Eligibility: Females, Ages 18–45, Does Not Accept Healthy Volunteers

This within-person, crossover, 3-condition, placebo-controlled study compares the impact of three perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The three conditions are (1) perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2) perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3) perimenstrual withdrawal from both estradiol and progesterone during placebo.

Suubi4Her: A Combination Intervention Addressing HIV Risk Behaviors Among Older Adolescent Girls Transitioning Into Adulthood in Uganda

Study Type: Interventional
Start Date: March 23, 2018
Location: Masaka, Uganda
Eligibility: Females, Ages 14–17, Accepts Healthy Volunteers

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

Identifying Neural Mechanisms of PTSD Symptom Reduction Induced by Estrogen

Study Type: Interventional
Start Date: November 29, 2017
Locations: Chicago, Illinois; Philadelphia, Pennsylvania
Eligibility: Females, Ages 18–45, Accepts Healthy Volunteers

This study aims to first identify the optimal estradiol (E2) dose that best engages the fear extinction network among healthy women using oral contraceptives. The second objective is to then evaluate the impact of this optimal E2 dose, when administered in conjunction with 5 sessions of Prolonged Exposure therapy, on the functional activity of the fear extinction network of women with clinically significant posttraumatic stress disorder symptoms. This approach will elucidate the neural mechanisms underlying effective exposure treatment for these symptoms, and will document how estradiol could be used as adjunct to enhance the outcome of extinction-based therapies.

Effects of Glucocorticoids on Cognition in HIV-infected Women

Study Type: Interventional
Start Date: November 20, 2017
Location: Baltimore, Maryland
Eligibility: Females, Ages 18–65, Does Not Accept Healthy Volunteers

Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.

Neuroeconomics of Social Behavior Following Trauma Exposure

Study Type: Observational
Start Date: November 14, 2017
Location: Belmont, Massachusetts
Eligibility: Females, Ages 18–45, Accepts Healthy Volunteers

This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed women. By also gathering self-report measures of social anhedonia, performance on non-social and social reward valuation tasks, and measures of real-world social functioning including social network size, we aim to specify how alterations in social reward processing result in social withdrawal and functional impairment.

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Study Type: Interventional
Start Date: September 1, 2017
Location: Denver, Colorado
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among pregnant women with elevated depressive symptoms. Half of the women will be randomized to receive IPT, and the other half will get Treat As Usual, provided via behavioral health in the hospital.

Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders

Study Type: Observational
Start Date: July 10, 2017
Location: Eugene, Oregon
Eligibility: Females, Ages 18–34, Does Not Accept Healthy Volunteers

Most people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews.

In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.

Feasibility of Implementing a Mental Health Care Program and Home-based Training for Mothers of Children With Autism Spectrum Disorder in an Urban Population in Bangladesh

Study Type: Interventional
Start Date: April 1, 2017
Location: Dhaka, Bangladesh
Eligibility: Females, Ages 18–50, Does Not Accept Healthy Volunteers

Background (brief):

The global burden of depression accounts for 2.5% of global DALYs, and in South Asia the estimate is 13.3 % of DALYs per 100,000 populations. Mothers of children with Autism Spectrum Disorder (ASD) have reported higher level of depression than mothers of children with other developmental disorder and the prevalence of ASD is high in Asian countries. In Bangladesh 16% of adults suffer from depression and a recent study conducted in Bangladesh has documented a high prevalence of depression among mothers of children with ASD (45%). Mothers are the life time care givers of children with ASD, and a high burden of depression is likely negatively impact on the ability of the mothers to provide care to children at home. Mental health is not addressed in Bangladesh and there is scarcity of qualified providers.

Objectives:

The investigators propose to pilot the feasibility of a package intervention including implementation of mental health care and home based training program for the mothers of children with ASD integrated in the regular activities of the special schools that offer ASD care in Dhaka city in Bangladesh.

Methods:

The study will be conducted in 2 selected special schools over 15 months. In the first stage, the investigators will set up the study in two schools and identify various stakeholders for qualitative assessment of the barriers of implementing the intervention at the institutional level, individual level, family level, provider level, policy maker level and at the level of the state. Research staff will identify mothers 18 years of age or older who has a child with ASD between 3 and 17 years of age enrolled in the school. Following consent, data collector will obtain data and assess current major depressive episode (MDE) of the eligible mothers following a standard diagnostic tool (SCID-I). All mothers diagnosed as having MDE will be invited to participate in the intervention (intervention mothers) and the investigators will assess the performances in children with ASD by applying ASD Diagnostic Check-list (ADCL).

In the second stage, investigators will implement interventions over 4-6 months, including (a) implementing mental health care services at the selected schools targeting the intervention mothers, and (b) organizing training sessions of the intervention mothers for supporting child care at home for enhancing child performances. Every month a psychiatrist will visit each school for providing necessary advice and treatment to the intervention mothers or suggest referral to hospital care, if necessary.

One special educator will be deployed at each school who will organize structured training sessions for educating the intervention mothers by using BCC materials developed and validated by icddr,b in the local setting. The special educators will conduct multiple group sessions including 5-8 mothers in each group for covering the 6 modules over 2 weeks time, and follow up intervention mothers at home every month for conducting refresher's training, documenting the need of additional training supports, and linking mother with an ASD expert for helping mothers taking a decision.

In stage 3, investigators will conduct post intervention qualitative survey with various stakeholders who would be involved with implementing the intervention and participated in the baseline qualitative survey. End line assessment will be conducted of current major depressive episode (MDE) among all mothers and assess the performance of the children of intervention mothers in order to assess the impact of the training at home.

Outcome measures/variables:

The primary outcome of the study is to assess the feasibility of institutionalizing the combined intervention of mental health care supports and the home based training program of the mothers who would be diagnosed as having major current major depressive episode. The primary outcome will be assessed by obtaining the perspectives of various stakeholders. The following parameters will be assessed for measuring feasibility of the proposed intervention.

Acceptability, Adaptability, Demands, Practicality, Implementation, Integration

The secondary outcomes will include estimating the impact of the combined interventions on the prevalence rate of maternal depression (MDE), individual performances of children, and cost of intervention. Adaptation of the proposed strategy, if feasible will help the mothers of children with ASD become skilled workforces for filling in the gap of the special educators in resource poor settings, and extension of these services to more children with ASD.

Remote Supervision for Implementing Collaborative Care for Perinatal Depression

Study Type: Interventional
Start Date: April 1, 2017
Location: Seattle, Washington
Eligibility: Females, Ages 18–45, Does Not Accept Healthy Volunteers

This study evaluates the impact of a longitudinal remote consultation (LRC) implementation strategy for collaborative care depression treatment among perinatal women. All participating health centers will receive training in collaborative care. Cluster randomization will be used to assign the addition of LRC to select health centers. Differences in implementation success, clinical outcomes, and costs will be compared after a 12 month implementation period and 13-21 month sustainment period.

The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood

Study Type: Interventional
Start Date: January 24, 2017
Location: Chapel Hill, North Carolina
Eligibility: Females, Ages 45–60, Accepts Healthy Volunteers

Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.

Reward Systems and Food Avoidance in Eating Disorders

Study Type: Interventional
Start Date: November 30, 2016
Location: New York, New York
Eligibility: Females, Ages 12–18, Accepts Healthy Volunteers

The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. By studying why individuals with AN are disgusted by food or other eating situations, the researchers will be able to understand more about the neurobiological pathways that lead to restricting food intake and food avoidance. This study also aims to find whether one of two short-term interventions (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the treatments affect food avoidance. IE is an intervention that helps reduce anxiety about eating. FBT is an intervention that motivates patients to eat through working with family to increase the value of eating and decrease the value of avoiding foods.

A Study Examining Adolescents With Non-Suicidal Self-Injury

Study Type: Observational
Start Date: August 31, 2016
Location: Minneapolis, Minnesota
Eligibility: Females, Ages 12–16, Accepts Healthy Volunteers

This study will examine longitudinal brain development in young adolescent girls with a history of Non-Suicidal Self-Injury (NSSI). Specifically, three constructs outlined by the the Research Domains Criteria (RDoC) will be examined through self-assessment, MRI, and a cognitive battery.

Pregnancy and Anxious Thoughts: The Role of the Immune and Endocrine Systems

Study Type: Observational
Start Date: June 24, 2016
Location: Baltimore, Maryland
Eligibility: Females, Ages 18 and Older, Accepts Healthy Volunteers

The aim of the proposed research is to identify the clinical and biological phenotypes that define perinatal anxiety. The importance of this research to public health is that it will help to identify women at high risk, and will also serve as the basis for further studies that would identify genetic and epigenetic markers of risk and lead to research to identify novel treatment targets. The research is based upon preliminary data demonstrating a relationship between inflammatory cytokines and Trait anxiety in pregnancy; between progesterone and postpartum anxiety; and between allopregnanolone and obsessive symptoms in pregnancy. The proposed research will build upon these preliminary findings by prospectively examining the clinical features of anxiety in a cohort of pregnant women and healthy matched controls, and by analyzing blood samples from the same cohort for inflammatory cytokines, reproductive hormones, and immune cell types. The proposed study will therefore identify the clinical and biological phenotypes that characterize perinatal anxiety and will identify potential novel targets for treatment.

Microbiome-mediated Weight, Anxiety, and Stress Dysregulation in Anorexia Nervosa

Study Type: Observational
Start Date: April 30, 2016
Location: Chapel Hill, North Carolina
Eligibility: Females, Ages 15–45, Accepts Healthy Volunteers

The purpose of this research study is to analyze the microorganisms residing in the gut of patients with anorexia nervosa. Research has begun to link changes in the intestinal microbiota with diseases such as inflammatory bowel disease (IBS), asthma, and obesity, but although some studies have investigated the intestinal microbiota in overweight/obese individuals, very little is known about the intestinal microbiota in underweight individuals. The investigators aim to identify the enteric bacterial groups associated with adiposity, BMI, anxiety, and stress in patients with anorexia nervosa.

Stress & Premenstrual Symptoms Study

Study Type: Interventional
Start Date: January 31, 2016
Location: Philadelphia, Pennsylvania
Eligibility: Females, Ages 18–50, Accepts Healthy Volunteers

This is a pilot study that aims to evaluate the psychophysiology of premenstrual mood disorders (PMDs) at baseline and after treatment with sertraline. Participants will include women with PMDs and healthy male and female controls. Participation involves a baseline visit to determine eligibility and three study visits that include questionnaires and stress reactivity assessment via an acoustic startle paradigm, cortisol, and immune markers, as well as hormone and genetic measures. Female participants with PMDs will receive sertraline during the premenstrual phase.

Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Study Type: Interventional
Start Date: December 31, 2015
Location: Miami, Florida
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and prescribed traditional gender roles) that have been associated with medication nonadherence or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers

Study Type: Observational
Start Date: May 31, 2014
Location: Baltimore, Maryland
Eligibility: Females, Ages 18–65, Accepts Healthy Volunteers

Through a recent cross species translational experiment, researchers have identified a set of epigenetic marks capable of predicting postpartum depression with greater than 85% accuracy. The researchers are looking to identify a group of women from both the general population and those with a history of mood disorders who are at risk for postpartum depression and obtain brain imaging data at a postpartum time period prior to the onset of depressive symptoms and compare it with those obtained during depressive episodes. The researchers will also evaluate the efficacy of postpartum depression biomarker prediction.

Neural Components Underlying the Treatment of Adolescent Depression

Study Type: Interventional
Start Date: October 31, 2012
Location: Belmont, Massachusetts
Eligibility: Females, Ages 13–18, Accepts Healthy Volunteers

The goal of the study is to examine how cognitive behavioral therapy (CBT), a common treatment for adolescent depression, affects brain functioning. Depressed adolescents will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. EEG (electroencephalography) measures brain activity by recording the electrical activity along the scalp caused by the firing of neurons within the brain. They will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long and held once a week for 12 weeks. Before their third therapy session, participants will complete a computer task while EEG data are recorded. After completing the treatment, the participants will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1, 3, and 6 months after completing the treatment.

This study will also include healthy control participants. They will complete an initial assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording. Three weeks later, they will return to complete a behavioral task while EEG data are recorded. Twelve weeks after the initial assessment, they will complete a final assessment, which will include questionnaires, computer tasks, and an EEG recording.

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

Study Type: Interventional
Start Date: March 31, 2008
Location: Atlanta, Georgia
Eligibility: Females, Ages 18–64, Does Not Accept Healthy Volunteers

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

The Effects of Reproductive Hormones on Mood and Behavior

Study Type: Observational
Start Date: April 25, 1992
Location: Bethesda, Maryland
Eligibility: Females, Ages 18–50, Accepts Healthy Volunteers

This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women.

The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS.

This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088).

At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

A Treatment Study for Premenstrual Syndrome (PMS)

Study Type: Observational
Start Date: March 9, 1990
Location: Bethesda, Maryland
Eligibility: Females, Ages 18–50, Does Not Accept Healthy Volunteers

This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome.

Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS.

PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174).

At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

Perimenopause-Related Mood and Behavioral Disorders

Study Type: Observational
Start Date: July 12, 1988
Location: Bethesda, Maryland
Eligibility: Females, Ages 40–65, Accepts Healthy Volunteers

The purpose of this study is to investigate mood and behavior changes in the time period surrounding and including menopause. This is an observational study; volunteers who participate will not receive any new or experimental therapies.

Controversy exists regarding the relationship between estrogen and progesterone (gonadal steroid) changes and midlife-onset depression. This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders.

Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression. Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators (SERMS).

A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning.

Study of Premenstrual Syndrome and Premenstrual Dysphoria

Study Type: Observational
Start Date: August 24, 1981
Location: Bethesda, Maryland
Eligibility: Females, Ages 18–50, Accepts Healthy Volunteers

The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).

Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group....