AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Information source: Mclean Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Testosterone gel (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: Mclean Hospital
Official(s) and/or principal investigator(s):
Harrison G Pope, M.D., Principal Investigator, Affiliation: Mclean Hospital
Stuart N Seidman, M.D., Principal Investigator, Affiliation: Columbia University
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
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.
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 21-item Hamilton Depression Rating Scale Score (HAM-D)
Secondary outcome: Montgomery Asberg Depression Rating Scale (MADRS)
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.
Minimum age: 30 Years.
Maximum age: 65 Years.
- 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
- HAM-D score >12
- 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.
Locations and Contacts
The Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel
McLean Hospital, Belmont, Massachusetts 02478, United States
Starting date: April 2006
Last updated: November 17, 2010