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Testosterone Antidepressant Augmentation in Women

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ClinicalTrials.gov Identifier: NCT01783574
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Lawley Pharmaceuticals
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Drug: Testosterone Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Collaborative Study: Testosterone Antidepressant Augmentation in Women
Actual Study Start Date : August 2013
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783574


Locations
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
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
  Study Documents (Full-Text)

Documents provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
Study Protocol  [PDF] May 19, 2017
Statistical Analysis Plan  [PDF] February 1, 2017


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 ( Other Identifier: National Institute of Mental Health )
First Posted: February 5, 2013    Key Record Dates
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Antidepressive Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Psychotropic Drugs