N/A
N=101
Testosterone Antidepressant Augmentation in Women
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01783574 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Depressive Symptom Severity — 15.3; 14.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Testosterone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptom Severity |
15.3; 14.1 | — |
| SECONDARY Fatigue |
4.0; 3.7 | — |
| SECONDARY Sexual Dysfunction |
45.1; 47.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01783574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.