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 : June 6, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Testosterone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
- 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.
- 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.
- 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, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Karen Miller, MD||Massachusetts General Hospital|
|Principal Investigator:||Maurizio Fava, MD||Massachusetts General Hospital|
|Principal Investigator:||Linda L Carpenter, MD||Butler Hospital|
Documents provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
|Responsible Party:||Karen Klahr Miller, MD, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital|
|Other Study ID Numbers:||
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:||June 6, 2018|
|Last Verified:||May 2018|
Major Depressive Disorder (MDD)
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal