Estrogen and Perimenopausal Depression

NCT ID: NCT00229450

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-08-31

Brief Summary

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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

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Conditions

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Depressive Disorder, Major Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

0.625 mg/day of conjugated estrogen

Group Type EXPERIMENTAL

Estrogen

Intervention Type DRUG

0.625 mg/day of conjugated Estrogen

Placebo

Daily placebo for conjugated estrogen

Group Type PLACEBO_COMPARATOR

Estrogen

Intervention Type DRUG

0.625 mg/day of conjugated Estrogen

Interventions

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Estrogen

0.625 mg/day of conjugated Estrogen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melinda L. Morgan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Neuropsychiatric Institute & Hospital

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Morgan ML, Cook IA, Rapkin AJ, Leuchter AF. Estrogen augmentation of antidepressants in perimenopausal depression: a pilot study. J Clin Psychiatry. 2005 Jun;66(6):774-80. doi: 10.4088/jcp.v66n0617.

Reference Type BACKGROUND
PMID: 15960574 (View on PubMed)

Cook IA, Morgan ML, Dunkin JJ, David S, Witte E, Lufkin R, Abrams M, Rosenberg S, Leuchter AF. Estrogen replacement therapy is associated with less progression of subclinical structural brain disease in normal elderly women: a pilot study. Int J Geriatr Psychiatry. 2002 Jul;17(7):610-8. doi: 10.1002/gps.644.

Reference Type BACKGROUND
PMID: 12112157 (View on PubMed)

Other Identifiers

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06806-001

Identifier Type: -

Identifier Source: secondary_id

04-05-088

Identifier Type: -

Identifier Source: secondary_id

NARSAD06806-001

Identifier Type: -

Identifier Source: org_study_id

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