Testosterone Antidepressant Augmentation in Women

Not Applicable

Completed

• Conditions: Depression
• Interventions: Drug: Placebo; Drug: Testosterone

• Registration Number: NCT01783574
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Study Start: 2013-08
• Primary Completion: 2017-01-27
• Study Completion: 2017-01-27
• Results First Submitted: 2018-01-18
• Results First Submitted QC: 2018-03-08
• Results First Posted: 2018-04-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Testosterone	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.

Primary Outcome Measures

Name	Time	Method
Depressive Symptom Severity	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

Name	Time	Method
Fatigue	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	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.

Trial Locations

Locations (2)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States