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Transforming the understanding
and treatment of mental illnesses.

Studies Recruiting Only Women

Mental disorders affect women and men differently — some disorders are more common in women or may be characterized by different symptoms in women and men. 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.

A Wearable Morning Light Treatment for Postpartum Depression

Study Type: Interventional
Start Date: June 23, 2021
Location: Ann Arbor, Michigan
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).

Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.

The hypotheses regarding the bright light versus the placebo dim light of the study are:

- morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression

- morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms.

- morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Study Type: Interventional
Start Date: June 8, 2021
Locations: Jacksonville, Florida; Chicago, Illinois; Johannesburg, Gauteng, South Africa
Eligibility: Females, Ages N/A and Older, Does Not Accept Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Study Type: Interventional
Start Date: May 1, 2021
Locations: Homa Bay, Kenya; Kisumu, Kenya; Siaya, Kenya
Eligibility: Females, Ages N/A and Older, Accepts Healthy Volunteers

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa

Study Type: Interventional
Start Date: April 12, 2021
Location: Cape Town, South Africa
Eligibility: Females, Ages 18 and Older, Accepts Healthy Volunteers

Despite high levels of adherence motivation during pregnancy, HIV treatment adherence and engagement in care is difficult for women in the postpartum period. Supporting women during the transition from pregnancy to postpartum is imperative to sustaining HIV treatment adherence during this period. The investigators are conducting a small scale pilot study of a behavioral Transition Theory-based intervention to support ART adherence and engagement in ART services among pregnant and postpartum women living with HIV.

PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

Study Type: Interventional
Start Date: March 1, 2021
Location: Kisumu, Kenya
Eligibility: Females, Ages N/A and Older, Accepts Healthy Volunteers

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

A Randomized Trial of ImpACT+, a Coping Intervention for HIV Infected Women With Sexual Trauma in South Africa

Study Type: Interventional
Start Date: February 18, 2021
Location: Cape Town, South Africa
Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The investigators propose a full-scale randomized controlled trial to examine the effect of ImpACT+ on clinical outcomes in the period after antiretroviral therapy (ART) initiation and to understand mental health and behavioral mechanisms through which viral suppression can be achieved. ImpACT+ will target women who are newly initiating ART in order to take advantage of a window of opportunity in HIV care and maximize care engagement. The aims are to test the effectiveness of ImpACT+ and explore its potential for implementation.

Improving Therapeutic Learning for PTSD

Study Type: Interventional
Start Date: February 18, 2021
Location: Madison, Wisconsin
Eligibility: Females, Ages 21–50, Accepts Healthy Volunteers

The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.

Collaborative Care for Perinatal Depression Care in Vietnam

Study Type: Interventional
Start Date: December 1, 2020
Location: Cần Thơ, Vietnam
Eligibility: Females, Ages 16–45, Does Not Accept Healthy Volunteers

Depression is the most common medical disorder of pregnancy, and suicide, most frequently found in women with depression, is a major source of maternal mortality. Perinatal depression affects approximately 15% of women in pregnancy and the year postpartum and affects both women and their children, both medically and as a result of impairment in the ability to care for self and others. In low- and middle-income countries (LMICs) where food insecurity can be severe, growth stunting is seen among the infants of women with untreated depression. Fortunately, effective treatment of perinatal depression with antidepressant medications and evidence-based psychosocial interventions (such as collaborative care) mitigates these risks. Yet there are a range of obstacles within LMICs to the delivery of services for perinatal depression and maternal suicide prevention, including a lack of awareness of this disorder and related evidence-based treatments, stigma among patients and providers, scarcity of specialty mental health care providers, and the lack of health information technology supports for the longitudinal care of chronic illness.

Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya

Study Type: Interventional
Start Date: October 5, 2020
Locations: Mariakani, Kilifi, Kenya; Mtwapa, Kilifi, Kenya; Vipingo, Kilifi, Kenya; Likoni, Mombasa, Kenya; Ambira, Siaya, Kenya; Bondo, Siaya, Kenya; Malanga, Siaya, Kenya; Sigomere, Siaya, Kenya; Ukwala, Siaya, Kenya; Yala, Siaya, Kenya; Siaya, Kenya
Eligibility: Females, Ages N/A and Older, Does Not Accept Healthy Volunteers

The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts for providers) to increase retention in guideline-adherent prevention of mother-to-child transmission of HIV services (PMTCT) and to increase viral suppression and appropriate clinical action through the extended period of 6 months postpartum, compared to standard of care PMTCT services in a matched, cluster randomized controlled trial.

Self-Control in Bulimia Nervosa

Study Type: Interventional
Start Date: September 18, 2020
Location: New York, New York
Eligibility: Females, Ages 18–35, Accepts Healthy Volunteers

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).

Neurobiology of Bulimia Nervosa

Study Type: Interventional
Start Date: February 24, 2020
Location: Chapel Hill, North Carolina
Eligibility: Females, Ages 18–42, Does Not Accept Healthy Volunteers

This pilot study experimentally manipulates ovarian hormones to examine the direct impact of estrogen (E2) and progesterone (P4) on binge eating symptom burden and the behavioral reward response in women with bulimia nervosa (n=15). This is completed by taking medications that change ovarian hormone levels. This line of research could lead to the development of pharmacological interventions developed to target specific areas of the brain, brain receptors, or pathways identified to be involved in the mechanism underlying ovarian hormone change and binge eating.

Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

Study Type: Interventional
Start Date: January 2, 2020
Location: Chapel Hill, North Carolina
Eligibility: Females, Ages 22–45, Accepts Healthy Volunteers

The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.

Neuroendocrine Risk for PTSD in Women

Study Type: Interventional
Start Date: November 11, 2019
Location: Atlanta, Georgia
Eligibility: Females, Ages 18–35, Does Not Accept Healthy Volunteers

This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase):

1. PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD

2. Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD

3. Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported)

Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.

Adolescent Attention to Emotion Study

Study Type: Interventional
Start Date: October 16, 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.

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.

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
Locations: Stanford, California; 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.

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.

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.

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 Role of Hormones in Postpartum Mood Disorders

Study Type: Interventional
Start Date: April 26, 1996
Location: Bethesda, Maryland
Eligibility: Females, Ages 18–50, Does Not Accept Healthy Volunteers

Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone.

The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).

Perimenopause-Related Mood and Behavioral Disorders

Study Type: Observational
Start Date: March 5, 1989
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: March 9, 1984
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.