Completed

Evaluation of Perimenopause-Related Mood and Behavioral Disorders in Women

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Study Aim

This study aims to observe and understand the mood and behavioral changes in women during perimenopause, using standardized rating scales and daily symptom assessments, along with measuring plasma hormone levels, including neurosteroids.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior+2

+ Mental Disorders

+ Behavioral Symptoms

From 40 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 1989
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 6, 1989

Actual date on which the first participant was enrolled.

This study focuses on women experiencing mood and behavioral changes related to perimenopause, a phase leading up to menopause. The main goal is to understand the role of hormonal changes in causing depression during this period. The study is important as it aims to provide clarity on a controversial topic and could improve the diagnosis and treatment of perimenopausal depression. The study seeks women who are in the perimenopause stage and will evaluate them through various methods including a psychiatric interview, medical history review, physical exam, and blood and urine tests. During the study, participants will undergo a series of evaluations. These include completing standard questionnaires like the Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale. They will also need to rate their symptoms daily and provide blood samples for hormone level checks, including neurosteroid levels. The study does not involve any treatment but aims to collect valuable data that could potentially link depression to changes in reproductive hormones during the perimenopause phase.

Official TitleThe Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders
NCT00001231
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1158 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressionMood Disorders

Criteria

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
CompletedOne Study Center
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