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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00676676 |
Purpose
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:
However, testosterone administration in women with SSRI or SNRI-resistant depression has not been studied.
| Condition | Intervention |
|---|---|
|
Depression |
Drug: Testosterone |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Effects of Testosterone in Women With Depression: A Pilot Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Testosterone
Testosterone Patch 300mcg replaced every 3-4 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Danielle J. Brick, BA | 617-724-0785 | dbrick@partners.org |
| Contact: Victoria E. Ameral, BA | 617-724-9458 | vameral@partners.org |
| United States, Massachusetts | |
| Depression Clinical and Research Program | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Sub-Investigator: Roy Perlis, MD | |
| Principal Investigator: | Karen K Miller, MD | Massachsuetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Karen K. Miller ) |
| Study ID Numbers: | 2007p000348 |
| Study First Received: | May 8, 2008 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00676676 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Depression Major Depressive Disorder |
|
Depression Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Depressive Disorder Hormones Pharmacologic Actions |
Behavioral Symptoms Testosterone 17 beta-cypionate Anabolic Agents Testosterone Mental Disorders Therapeutic Uses Mood Disorders Androgens |