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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304746
• Other study ID #: 2005P-001667
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: November 17, 2010
• Start date: April 2006
• Est. completion date: April 2009

Study information

• Verified date: November 2010
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Tel-Hashomer
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (1)

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 antide — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No