MedTrace Logo

Testosterone Antidepressant Augmentation in Women

NCT01783574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2018-06-06

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Testosterone

DRUG

Placebo

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Lawley Pharmaceuticals

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Karen Miller, MD · Massachusetts General Hospital

  • Maurizio Fava, MD · Massachusetts General Hospital

  • Linda L Carpenter, MD · Butler Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-01-27
Completion
2017-01-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783574 on ClinicalTrials.gov