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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00304746
First received: March 16, 2006
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
Results First Received: September 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: Testosterone gel
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at two sites – McLean Hospital in Belmont Massachusetts, USA and the Chaim Sheba Medical Center in Tel Hashomer, Israel. Using advertisements at each site, we recruited men age 30-65 with major depressive disorder incompletely responsive to a serotonergic antidepressant, and showing a total testosterone level ≤ 350 ng/dL.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At baseline, participants began a 1-week, single-blind placebo lead-in of one packet of placebo gel daily. Men exhibiting ≥ 50% improvement on either the Hamilton Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.

Reporting Groups
  Description
Testosterone Gel AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Placebo Gel Placebo gel identical in appearance to the testosterone gel

Participant Flow:   Overall Study
    Testosterone Gel     Placebo Gel  
STARTED     50     50  
COMPLETED     50     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Testosterone Gel AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Placebo Gel Placebo gel identical in appearance to the testosterone gel
Total Total of all reporting groups

Baseline Measures
    Testosterone Gel     Placebo Gel     Total  
Number of Participants  
[units: participants]
 		  50     50     100  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     50     50     100  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  50.6  ± 8.2     49.9  ± 7.1     50.3  ± 7.7  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     50     50     100  
Region of Enrollment  
[units: participants]
 		     
United States     29     24     53  
Israel     21     26     47  



  Outcome Measures
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1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Secondary:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment) ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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Time Frame Adverse events were assessed at all study visits throughout the eight-week blinded phase of the study.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Testosterone Gel AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Placebo Gel Placebo gel identical in appearance to the testosterone gel

Other Adverse Events
    Testosterone Gel     Placebo Gel  
Total, other (not including serious) adverse events      
# participants affected / at risk     3/50     0/50  
Nervous system disorders      
headache *    
# participants affected / at risk     3/50 (6.00%)     0/50 (0.00%)  
# events     3     0  
* Events were collected by non-systematic assessment



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The small number of participants limited statistical power. Also, the study recruited “treatment-resistant” men, who are often poorly responsive. For a detailed discussion, see the published report of the study.  


Results Point of Contact:  
Name/Title: Harrison G Pope Jr., M.D.
Organization: McLean Hospital
phone: 617-855-2911
e-mail: hpope@mcLean.harvard.edu


Publications of Results:


Responsible Party: Harrison G. Pope, Jr., M.D., McLean Hospital
ClinicalTrials.gov Identifier: NCT00304746     History of Changes
Other Study ID Numbers: 2005P-001667
Study First Received: March 16, 2006
Results First Received: September 24, 2010
Last Updated: November 17, 2010
Health Authority: United States: Institutional Review Board