Status:
COMPLETED
Effects of Testosterone in Women With Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Depression
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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 ade...
Eligibility Criteria
Inclusion
- Female, age 18-75
- Written informed consent
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (by Structured Clinical Interview for DSM-IV (SCID)) for Major Depressive Disorder
- Meet DSM-IV criteria for a current major depressive episode, as assessed by SCID
- Montgomery-Asberg Depression Rating Scale (MADRS) greater than or equal to 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
- 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, Dehydroepiandrosterone (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 (greater than 50%) in the past year)
- Alanine aminotransferase (ALT) greater than 1.5 times the upper limit of normal.
- Creatinine greater than 1.5 times upper limit of normal
- History of a hormone-responsive cancer
- History of congestive heart failure
- MADRS greater than 31
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00676676
Start Date
March 1 2007
End Date
October 1 2008
Last Update
November 30 2012
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