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Testosterone Antidepressant Augmentation in Women

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
Lawley Pharmaceuticals
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital Identifier:
First received: February 1, 2013
Last updated: February 28, 2017
Last verified: February 2017
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.

Condition Intervention
Depression Drug: Testosterone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Collaborative Study: Testosterone Antidepressant Augmentation in Women

Resource links provided by NLM:

Further study details as provided by Karen Klahr Miller, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Baseline, Week 8 ]

Secondary Outcome Measures:
  • Fatigue [ Time Frame: Baseline, Week 8 ]
  • Sexual dysfunction [ Time Frame: Baseline, Week 8 ]

Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: May 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Testosterone
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Drug: Testosterone
Other Name: AndroFeme 1(testosterone 1% w/v cream)
Placebo Comparator: Placebo
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Drug: Placebo


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female, age 21-75
  2. Major depressive disorder including MADRS>/=12
  3. 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:

  1. Serious suicide or homicide risk, as assessed by evaluating clinician
  2. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
  3. 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.
  4. Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
  5. Currently treated with typical or atypical antipsychotic medications, or lithium
  6. Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos
  7. Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
  8. Any investigational psychotropic drug within the last thirty days
  9. 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)
  10. ALT > 3x upper limit of normal or creatinine> 3x upper limit
  11. History of a hormone-responsive cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01783574

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Lawley Pharmaceuticals
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
Principal Investigator: Linda L Carpenter, MD Butler Hospital
  More Information

Responsible Party: Karen Klahr Miller, MD, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital Identifier: NCT01783574     History of Changes
Other Study ID Numbers: 2012D000537
R34MH09931501A1 ( Other Identifier: National Institute of Mental Health )
Study First Received: February 1, 2013
Last Updated: February 28, 2017

Keywords provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
Major Depressive Disorder (MDD)

Additional relevant MeSH terms:
Behavioral Symptoms
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Antidepressive Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Psychotropic Drugs processed this record on June 22, 2017