Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304746
Status:
COMPLETED
Last Update Posted:
2010-11-24
First Post:
2006-03-16
Brief Title:
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 memoryand 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None