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

NCT ID: NCT00304746

Last Updated: 2010-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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testosterone gel

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

Group Type ACTIVE_COMPARATOR

Testosterone gel

Intervention Type DRUG

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

placebo gel

Placebo gel

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Testosterone gel

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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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AndroGel

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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McLean Hospital

Principal Investigators

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Harrison G Pope, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Stuart N Seidman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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United States Israel

References

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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.

Reference Type RESULT
PMID: 20520285 (View on PubMed)

Other Identifiers

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2005P-001667

Identifier Type: -

Identifier Source: org_study_id