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Effects of Testosterone in Women With Depression
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, January 2010
First Received: May 8, 2008   Last Updated: January 13, 2010   History of Changes
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:

  • Women with anorexia nervosa
  • Women who have low testosterone levels because their pituitary glands do not work
  • Men with SSRI-resistant depression.

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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • MADRS score [ Time Frame: screen, BL, 2wk, 4wk, 8wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IDS-SR [ Time Frame: BL, wk 2 ] [ Designated as safety issue: No ]
  • ESS [ Time Frame: BL, wk 2, wk 4, wk 8 ] [ Designated as safety issue: No ]
  • FSS [ Time Frame: BL, wk 2, wk 4, wk 8 ] [ Designated as safety issue: No ]
  • PFSF [ Time Frame: BL, wk 8 ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  • Female, age 18-75
  • Written informed consent
  • Meet DSM-IV criteria (by SCID) for Major Depressive Disorder
  • Meet DSM-IV criteria for a current major depressive episode, as assessed by SCID
  • MADRS > or = 16 at baseline visit
  • Currently treated with SSRI or SNRI, with or without adjunctive therapy, at an adequate dose (see adequate dose table below) for at least six weeks

Exclusion Criteria:

  • Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
  • Serious suicide or homicide risk, as assessed by evaluating clinician
  • Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic (including uncontrolled seizure disorder)
  • Substance use disorder active within last six months
  • Psychotic features (current episode or lifetime), as assessed by SCID
  • Laboratory evidence of untreated hypothyroidism
  • If treated hypothyroidism, significant change in levo-thyroxine dose within the prior three months
  • If receiving oral estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior three months
  • Use of androgens or androgen precursors, including testosterone, DHEA and methyltestosterone, within the prior three months
  • Any investigational psychotropic drug within the last two weeks
  • In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (>50%) in the past year)
  • Alanine aminotransferase (ALT) > 1.5x upper limit of normal.
  • Creatinine > 1.5x upper limit of normal
  • History of a hormone-responsive cancer
  • History of congestive heart failure
  • MADRS > 31
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676676

Contacts
Contact: Danielle J. Brick, BA 617-724-0785 dbrick@partners.org
Contact: Victoria E. Ameral, BA 617-724-9458 vameral@partners.org

Locations
United States, Massachusetts
Depression Clinical and Research Program Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Roy Perlis, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen K Miller, MD Massachsuetts General Hospital
  More Information

No publications provided

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

Keywords provided by Massachusetts General Hospital:
Depression
Major Depressive Disorder

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010