Testosterone Antidepressant Augmentation in Women



Status:Completed
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 75
Updated:6/7/2018
Start Date:August 2013
End Date:January 27, 2017

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Collaborative Study: Testosterone Antidepressant Augmentation in Women

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.


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
We found this trial at
2
sites
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Phone: 401-455-6349
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Karen Miller, MD
Phone: 617-724-1837
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Boston, MA
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