Effects of Testosterone in Women With Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00676676
• Date of registration: 08/05/2008
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Effects of Testosterone in Women With Depression
• Scientific title: Effects of Testosterone in Women With Depression: A Pilot Study
• Date of first enrolment: March 2007
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00676676
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Karen K Miller, MD
• Affiliation: Massachsuetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Drug: Testosterone

Primary Outcome(s)

Montgomery-Asberg Depression Rating Scale (MADRS) Scale [Time Frame: Baseline, 2-week, 8-week]

Secondary ID(s)

2007p000348

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)

Results

• Results available: Yes
• Date Posted: 30/11/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00676676