Testosterone Antidepressant Augmentation in Women

NCT01783574 | Completed Results DMC

• 2 other identifiers: 2012D000537R34MH09931501A1
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Depression; Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fatigue

  Week 8

• Sexual Dysfunction

  Week 8

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Testosterone DRUG

Also known as: AndroFeme 1(testosterone 1% w/v cream)

Testosterone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• Lawley Pharmaceuticals: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 32660299 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Karen K. Miller
• Organization: Massachusetts General Hospital

KKMILLER@MGH.HARVARD.EDU

617-726-3870

Study Officials

• Karen Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Linda L Carpenter, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: August 1, 2013
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: June 6, 2018
• Results First Posted: April 5, 2018

Record last verified: 2018-05

Locations

US (2)