Estrogen and Perimenopausal Depression

Phase 4

Completed

• Conditions: Depressive Disorder, Major; Menopause
• Interventions: Drug: Estrogen

• Registration Number: NCT00229450
• Lead Sponsor: University of California, Los Angeles

Brief Summary

During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2003-08
• Study Completion: 2004-08
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-29
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
• HAM-D between 10 and 17

Exclusion Criteria

• History of Psychosis, breast cancer, smoking, dementia, clotting disorders
• Current substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Estrogen	0.625 mg/day of conjugated estrogen
Placebo	Estrogen	Daily placebo for conjugated estrogen

Primary Outcome Measures

Name	Time	Method
Mood	6 weeks	17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.

Secondary Outcome Measures

Name	Time	Method
Memory	6 weeks	The Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.

Trial Locations

Locations (1)

UCLA Neuropsychiatric Institute & Hospital; 🇺🇸 Los Angeles, California, United States