AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment - Full Text View

Sponsor:	Mclean Hospital
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00304746

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Montgomery Asberg Depression Rating Scale [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Testosterone gel	Drug: Testosterone gel AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
2: Placebo Comparator	Drug: Placebo 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

No publications provided

Responsible Party:	McLean Hospital ( Harrison G. Pope, Jr., M.D. )
Study ID Numbers:	2005P-001667
Study First Received:	March 16, 2006
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00304746 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Depression
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Depressive Disorder, Major
Methyltestosterone
Depressive Disorder
Hormones
Pharmacologic Actions

Behavioral Symptoms
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents
Androgens

ClinicalTrials.gov processed this record on November 30, 2009