Depression: Dose Response Effects of Estrogen Augmentation in Mood and Memory in Perimenopausal Depression

Contact name: Melinda Morgan, Ph.D.

Phone: (310)-825-5028

Fax: (310)-285-7642

Email: melinda@ucla.edu

Disorder: Depression

Geographic location: Los Angeles, California

Other keywords: estrogen, augmentation, depression, menopause, antidepressant

Participant compensation: $60.00, free parking, free medication

Time commitment required: 5 visits over a 9 week period

Drug trial: Yes

Recruitment end date (approximate): September 8, 2006

Study criteria (i.e., age or gender requirements):
1. Female, between the age of 40 and 60.
2. Perimenopausal symptoms of hot flashes, night sweats, insomnia, impaired memory and/or irregular menstrual periods.
3. Non pregnant status.
4. At least 8 weeks on antidepressant medication.
5. Must meet DSM-IV (American Psychiatric Association,1994) criteria for major depressive disorder (MDD), in partial remission (symptoms of MDD are present, but no longer meet full criteria, or there is a period without any significant symptoms lasting less than 2 months), as confirmed by the Structured Clinical Interview for DSM IV (SCID)(Spitzer, 1994):
6. Ham-D score less than or equal to 17 but not less than 10.
7. At least two months since the termination of any previous estrogen treatment.
8. Normal mammogram, physical examination and pelvic examination within a year of entrance into the study.
9. Not suffering from a medical illness including diabetes, hypertension, clotting, disorders, breast cancer, obesity or
cardiac, pulmonary, renal or liver disease.
10. Non-smoker.

Exclusion criteria:
1. Use of medication other than antidepressants with significant central nervous activity.
2. Illicit drug use.
3. Axis I disorder of psychosis, substance abuse, dementia or bipolar disorder.
4. Medical illness as outlined above.
5. Use of herbal supplements or over-the-counter preparations for symptoms of perimenopause and/or depression
(including soy isoflavones, black cohash, wild yam, dong quai and St. John’s Wort) within the last two weeks.

Brief description of study:
We are studying the effects of 3 different doses of estrogen as an augmentation strategy for menopausal women who are taking antidepressant medication, but are experiencing depressive symptoms. This is a single blind study in which subjects will receive estrogen for all 9 weeks of the study and the dose may or may not vary over the course of the study. All doses will be between .5 mg and 2 mg of micronized estradiol. A total of 5 visits are required. Mood, memory, and serum hormone levels will be assessed at 4 of the 5 visits. Subjects will continue taking antidepressants as prescribed by their primary treating physician.

Additional information: