NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

The Evaluation of Women with Perimenopause-Related Mood and Behavioral Disorders

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

88-M-0131

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 40 Years
Max Age: 65 Years

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Mood;
Behavior;
Cognition;
Midlife;
Depression

Recruitment Keyword(s)

None

Condition(s)

Mood Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

-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.

-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.


--Back to Top--

Citations:

Sex and depression in the National Comorbidity Survey I: lifetime prevalence, chronicity and recurrence

Menopause-related affective disorders: a justification for further study

Estrogen replacement in perimenopause-related depression: a preliminary report

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001231

--Back to Top--