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

NCT00304746 | Completed Phase 4 Results

• 1 other identifier: 2005P-001667
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)

Study Arms (2)

testosterone gel

ACTIVE COMPARATOR

AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily

Drug: Testosterone gel

placebo gel

PLACEBO COMPARATOR

Placebo gel

Drug: Placebo

Interventions

Testosterone gel DRUG

AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.

Also known as: AndroGel

testosterone gel

Placebo DRUG

Placebo

placebo gel

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related 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 antidepressant treatment. J Clin Psychopharmacol. 2010 Apr;30(2):126-34. doi: 10.1097/JCP.0b013e3181d207ca.

  PMID: 20520285 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

The small number of participants limited statistical power. Also, the study recruited "treatment-resistant" men, who are often poorly responsive. For a detailed discussion, see the published report of the study.

Results Point of Contact

• Title: Harrison G Pope Jr., M.D.
• Organization: McLean Hospital

hpope@mcLean.harvard.edu

617-855-2911

Study Officials

• Harrison G Pope, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• Stuart N Seidman, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 20, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: November 24, 2010
• Results First Posted: November 17, 2010

Record last verified: 2010-11

Locations

US (1); IL (1)