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Estrogen and Perimenopausal Depression

University of California, Los Angeles (UCLA) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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