Effects of Testosterone in Women With Depression

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, 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