Phase 4 N=100 Randomized Quadruple-blind Treatment

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

Depressive Disorder, Major

Bottom Line

View on ClinicalTrials.gov: NCT00304746 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Nov 2010

Primary outcome: Primary: 21-item Hamilton Depression Rating Scale Score (HAM-D) — 13.5; 15.6 units on a scale — p=0.71

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Testosterone gel (Drug); Placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: Male
Sponsor: Mclean Hospital
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 21-item Hamilton Depression Rating Scale Score (HAM-D)	13.5; 15.6	0.71
SECONDARY Montgomery Asberg Depression Rating Scale (MADRS)	17.9; 19.9	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00304746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.