Testosterone Antidepressant Augmentation in Women
|ClinicalTrials.gov Identifier: NCT01783574|
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
|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.
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|