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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Testosterone gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: testosterone gel<br>AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily | Drug: Testosterone gel<br>* AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.<br>* Other names: AndroGel;|
| Placebo Comparator: placebo gel<br>Placebo gel | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 21-item Hamilton Depression Rating Scale Score (HAM-D) | The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression). | 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) | 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). | 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment) |