Depressive Disorder, Major, Menopause
Conditions
Keywords
depression, menopause, perimenopause, mood, memory, perimenopausal, antidepressant, estrogen
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.
Interventions
DRUGEstrogen
0.625 mg/day of conjugated Estrogen
Sponsors
National Alliance for Research on Schizophrenia and Depression
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood | 6 weeks | 17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed