Perimenopause-Related Mood and Behavioral Disorders
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ClinicalTrials.gov Identifier: NCT00001231 |
Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : January 30, 2023
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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.
Condition or disease |
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Mood Disorder |
Study Type : | Observational |
Estimated Enrollment : | 1900 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders |
Actual Study Start Date : | January 25, 1993 |

Group/Cohort |
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Healthy Women
The purpose of this protocol is to allow for the careful screening of healthy volunteers for participation in research protocols.
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premenopausal depressed women patients
The purpose of this protocol is to allow for the careful screening of patients for participation in research protocols.
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- Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale), symptom rating scales completed daily, and plasma hormone measures (includ... [ Time Frame: Ongoing ]Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels).
- Plasma ACTH and cortisol response to the o-CRH stimulation tests, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, and the results of the SCID interviews [ Time Frame: Ongoing ]Plasma ACTH and cortisol response to the o-CRH stimulation tests, selected variants in genomic profile (e.g., SNPs) and genome/exome sequencing, and the results of the SCID interviews

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Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
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Perimenopausal Subjects:
- History within the last one year of at least one month with perimenopause-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of functional impairment;
- Age 40-65;
- History of the onset of menstrual irregularity during the past six months but not greater than one year of amenorrhea (i.e., not postmenopausal);
- Biological evidence of a deterioration of normal ovarian activity, specifically, plasma FSH levels persistently elevated (> 14IU/L) (as recommended by the Stages of Reproductive Aging Workshop criteria (106)) drawn at two week intervals over a period of eight weeks;
- No prior estrogen replacement therapy for treatment of perimenopausal physical or emotional symptoms within the last six months; and
- In good medical health;
- Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols.
- A control group of age-matched perimenopausal women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought.
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Premenopausal women will be women who meet the following inclusion criteria for the longitudinal study participants:
- Regular menstrual cycle function (21-34 days);
- Absence of current mood or behavioral disturbance as determined by a structured diagnostic interview;
- Plasma gonadotropin levels in pre-perimenopausal range (<14 IU/L);
- In good medical health; and
- Medication free.
EXCLUSION CRITERIA:
- Primary general medical illness (i.e., appears to be causing the mood disorder);
- Current antidepressant therapy (since this is a screening protocol for subsequent treatment studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them;
- Current alcohol or substance abuse or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups);
- Pregnant or lactating women;
- Subjects who are unable to provide informed consent.
- NIMH employees, staff and their immediate family members will be excluded from the study per NIMH policy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001231
Contact: Peter J Schmidt, M.D. | (301) 496-6120 | peterschmidt@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 ccopr@nih.gov |
Principal Investigator: | Peter J Schmidt, M.D. | National Institute of Mental Health (NIMH) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00001231 |
Other Study ID Numbers: |
880131 88-M-0131 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | January 30, 2023 |
Last Verified: | January 26, 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | .Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Starting 24 months after final publication |
Access Criteria: | Data will be shared with dbGaP, BTRIS and NIMH Data Archive as determined by the Principal Investigator. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Mood Behavior Cognition Midlife Depression |
Mood Disorders Mental Disorders |