Effects of Testosterone in Women With Depression
The purpose of the study is to determine whether adding a low dose of testosterone to current antidepressant therapy improves depression and fatigue in women who remain depressed despite necessary adequate doses of anti-depressants. Testosterone will be given over an 8-week period.
Testosterone is a hormone that occurs naturally in the body. In women it comes from the ovaries and adrenal glands and is found in amounts that are ten to twenty times lower than in men.
In early research studies, testosterone has been shown to have some antidepressant effects in the following groups of subjects:
- Women with anorexia nervosa
- Women who have low testosterone levels because their pituitary glands do not work
- Men with Selective Serotonin Reuptake Inhibitor (SSRI)-resistant depression.
However, testosterone administration in women with SSRI or Serotonin-norepinephrine reuptake inhibitor (SNRI) -resistant depression has not been studied.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Testosterone in Women With Depression: A Pilot Study|
- Montgomery-Asberg Depression Rating Scale (MADRS) Scale [ Time Frame: Baseline, 2-week, 8-week ] [ Designated as safety issue: No ]the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).
|Study Start Date:||March 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Testosterone
Testosterone patch delivering 300mcg daily for 8-weeks.
Testosterone atch delivering 300mcg daily for 8-weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676676
|Principal Investigator:||Karen K Miller, MD||Massachsuetts General Hospital|