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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: Testosterone gel
Drug: Placebo

  Participant Flow

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Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

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


  Other Adverse Events


  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.


  More Information

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.


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
First Submitted: March 16, 2006
First Posted: March 20, 2006
Results First Submitted: September 24, 2010
Results First Posted: November 17, 2010
Last Update Posted: November 24, 2010