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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00304746
First received: March 16, 2006
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
 Drug: Testosterone gel
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • 21-item Hamilton Depression Rating Scale Score (HAM-D) [ Time Frame: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment) ] [ Designated as safety issue: No ]
    The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).


Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment) ] [ Designated as safety issue: No ]
    The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).


Enrollment: 100
Study Start Date: April 2006
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: testosterone gel
AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily
 Drug: Testosterone gel
AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
Other Name: AndroGel
Placebo Comparator: placebo gel
Placebo gel
 Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • 30-65 years old
  • Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
  • HAM-D score >12

Exclusion Criteria:

  • Current suicidal ideation
  • Substance abuse or dependence within the past year
  • Current or past psychotic symptoms
  • A history of bipolar disorder
  • A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
  • Other clinically significant medical condition
  • A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304746

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Israel
The Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
Mclean Hospital
Solvay Pharmaceuticals
Investigators
Principal Investigator: Harrison G Pope, M.D. Mclean Hospital
Principal Investigator: Stuart N Seidman, M.D. Columbia University
  More Information

Publications:

Responsible Party: Harrison G. Pope, Jr., M.D., McLean Hospital
ClinicalTrials.gov Identifier: NCT00304746     History of Changes
Other Study ID Numbers: 2005P-001667
Study First Received: March 16, 2006
Results First Received: September 24, 2010
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Antidepressive Agents
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013