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| 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: | 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| McLean Hospital | |
| Belmont, Massachusetts, United States, 02478 | |
| Israel | |
| The Chaim Sheba Medical Center | |
| Tel-Hashomer, Israel, 52621 | |
| Principal Investigator: | Harrison G Pope, M.D. | Mclean Hospital |
| Principal Investigator: | Stuart N Seidman, M.D. | Columbia University |
More Information
| 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 |
|
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 |