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

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 Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo; Drug: Testosterone gel

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Tel-Hashomer, Israel, 52621
    • The Chaim Sheba Medical Center
• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Mclean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: AndroGel
Placebo Comparator: placebo gel; Placebo gel	Drug: Placebo; Placebo

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: Solvay Pharmaceuticals
• Investigators: Principal Investigator: Harrison G Pope, M.D., Mclean Hospital; Principal Investigator: Stuart N Seidman, M.D., Columbia University

Publications and helpful links

General Publications

• Pope HG Jr, Amiaz R, Brennan BP, Orr G, Weiser M, Kelly JF, Kanayama G, Siegel A, Hudson JI, Seidman SN. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment. J Clin Psychopharmacol. 2010 Apr;30(2):126-34. doi: 10.1097/JCP.0b013e3181d207ca.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 16, 2006
• First Submitted That Met QC Criteria: March 16, 2006
• First Posted (Estimate): March 20, 2006

Study Record Updates

• Last Update Posted (Estimate): November 24, 2010
• Last Update Submitted That Met QC Criteria: November 17, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 2005P-001667