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”

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.

Study Type: Interventional

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

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Testosterone gel
  • AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Testosterone gel
• Placebo Comparator: 2

Primary Measures

• Hamilton Depression Rating Scale
  • Time Frame: 9 weeks
    Safety Issue?: No

Secondary Measures

• Montgomery Asberg Depression Rating Scale
  • Time Frame: 9 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mclean Hospital

Overall Clinical Trial Officials and Contacts

Harrison G Pope, M.D. Principal Investigator Mclean Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00304746

Study ID Number: 2005P-001667

ClinicalTrials.gov Identifier: NCT00304746

Health Authority: United States: Institutional Review Board