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AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment

NCT00304746 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-11-24

Study results available
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Summary

We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.

During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Testosterone gel

AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Harrison G Pope, M.D. · Mclean Hospital

  • Stuart N Seidman, M.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs

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 NCT00304746 on ClinicalTrials.gov