Skip to main content
OpenTrials
Completed

NCT Number: NCT01783574

Testosterone Antidepressant Augmentation in Women

The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive symptoms in women with Major Depressive Disorder (MDD) and antidepressant partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women with MDD and antidepressant partial/nonresponse, and low-dose testosterone augmentation improves fatigue and sexual dysfunction.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, age 21-75
  • Major depressive disorder including MADRS>/=12
  • Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.

Exclusion criteria

  • Serious suicide or homicide risk, as assessed by evaluating clinician
  • Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
  • Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
  • Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
  • Currently treated with typical or atypical antipsychotic medications, or lithium
  • Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos
  • Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
  • Any investigational psychotropic drug within the last thirty days
  • 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)
  • ALT > 3x upper limit of normal or creatinine> 3x upper limit
  • History of a hormone-responsive cancer

Treatment and study plan

Testosterone

Drug

Other names: AndroFeme 1(testosterone 1% w/v cream)

Placebo

Drug

Primary outcomes

  1. Depressive Symptom Severity

    Time frame: Week 8

    Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.

Secondary outcomes

  1. Fatigue

    Time frame: Week 8

    Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale.

  2. Sexual Dysfunction

    Time frame: Week 8

    Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Lawley Pharmaceuticals
  • National Institutes of Health (NIH)

Registry information

Official study title

Collaborative Study: Testosterone Antidepressant Augmentation in Women

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2013
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.