Estrogen and Perimenopausal Depression

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Menopause; Depressive Disorder, Major

Treatments: Drug: Estrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT00229450

NARSAD06806-001

04-05-088

06806-001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

0.625 mg/day of conjugated estrogen

Treatment:

Drug: Estrogen

Placebo

Placebo Comparator group

Description:

Daily placebo for conjugated estrogen

Treatment:

Drug: Estrogen