Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Mood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment
0.625 mg/day of conjugated estrogen
Intervention: Estrogen (Drug)
Placebo
Daily placebo for conjugated estrogen
Intervention: Estrogen (Drug)
Outcomes
Primary Outcomes
Mood
Time Frame: 6 weeks
17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.
Secondary Outcomes
- Memory(6 weeks)