Testosterone Antidepressant Augmentation in Women

Study Overview
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Brief Summary
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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.

Official Title
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Collaborative Study: Testosterone Antidepressant Augmentation in Women

Conditions
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Depression

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone<br>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<br> <br> * Other names: AndroFeme 1(testosterone 1% w/v cream);|
| Placebo Comparator: Placebo<br>Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptom Severity | 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. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale. | Week 8 | 
| Sexual Dysfunction | 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. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major Depressive Disorder (MDD)