Evaluation of Perimenopause-Related Mood and Behavioral Disorders in Women
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.
Data Collection
Collected from today forward - ProspectiveBehavior+2
+ Mental Disorders
+ Behavioral Symptoms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1158 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps