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

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ClinicalTrials.gov Identifier: NCT00304746
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : November 17, 2010
Last Update Posted : November 24, 2010
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Mclean Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2006
First Posted Date  ICMJE March 20, 2006
Results First Submitted Date  ICMJE September 24, 2010
Results First Posted Date  ICMJE November 17, 2010
Last Update Posted Date November 24, 2010
Study Start Date  ICMJE April 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
21-item Hamilton Depression Rating Scale Score (HAM-D) [ Time Frame: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment) ]
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00304746 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment) ]
The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Official Title  ICMJE A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment
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.

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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: Testosterone gel
    AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
    Other Name: AndroGel
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: testosterone gel
    AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily
    Intervention: Drug: Testosterone gel
  • Placebo Comparator: placebo gel
    Placebo gel
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2006)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00304746
Other Study ID Numbers  ICMJE 2005P-001667
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harrison G. Pope, Jr., M.D., McLean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Harrison G Pope, M.D. Mclean Hospital
Principal Investigator: Stuart N Seidman, M.D. Columbia University
PRS Account Mclean Hospital
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP