Clinical trial NCT01783574: Testosterone Antidepressant Augmentation in Women
Official title: Collaborative Study: Testosterone Antidepressant Augmentation in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Major Depressive Disorder (MDD)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Lawley Pharmaceuticals
First posted: 2013-02-05
Enrollment: 101
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Depressive Symptom Severity
timeFrame: Week 8
Secondary outcomes:
measure: Fatigue
timeFrame: Week 8
measure: Sexual Dysfunction
timeFrame: Week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Maurizio Fava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Linda L Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dichtel LE, Carpenter LL, Nyer M, Mischoulon D, Kimball A, Deckersbach T, Dougherty DD, Schoenfeld DA, Fisher L, Cusin C, Dording C, Trinh NH, Pedrelli P, Yeung A, Farabaugh A, Papakostas GI, Chang T, Shapero BG, Chen J, Cassano P, Hahn EM, Rao EM, Brady RO Jr, Singh RJ, Tyrka AR, Price LH, Fava M, Miller KK. Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study. Am J Psychiatry. 2020 Oct 1;177(10):965-973. doi: 10.1176/appi.ajp.2020.19080844. Epub 2020 Jul 14.