Testosterone Antidepressant Augmentation in Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Lawley Pharmaceuticals
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01783574
First received: February 1, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Collaborative Study: Testosterone Antidepressant Augmentation in Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Sexual dysfunction [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01783574

Contacts
Contact: Anu V Gerweck, NP 617-724-1837 avgerweck@partners.org
Contact: Ariana D Riccio, BS 617-726-2764 adriccio@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anu Gerweck, NP    617-724-1837    avgerweck@partners.org   
Principal Investigator: Karen Miller, MD         
Principal Investigator: Maurizio Fava, MD         
United States, Rhode Island
Butler Hospital Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Linda Carpenter, MD    401-455-6349    Linda_Carpenter_MD@Brown.edu   
Sub-Investigator: Linda Carpenter, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Lawley Pharmaceuticals
Investigators
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

No publications provided

Responsible Party: Karen Klahr Miller, MD, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01783574     History of Changes
Other Study ID Numbers: 2012D000537, R34MH09931501A1
Study First Received: February 1, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data Safety Monitoring Board

Keywords provided by Massachusetts General Hospital:
Depression
Major Depressive Disorder (MDD)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Central Nervous System Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014