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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
Enrollment 100
Recruitment Details 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 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Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.
Arm/Group Title Testosterone Gel Placebo Gel
Hide Arm/Group Description AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily Placebo gel identical in appearance to the testosterone gel
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Testosterone Gel Placebo Gel Total
Hide Arm/Group Description AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily Placebo gel identical in appearance to the testosterone gel Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
50.6  (8.2) 49.9  (7.1) 50.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
50
 100.0%
50
 100.0%
100
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
United States 29 24 53
Israel 21 26 47
1.Primary Outcome
Title 21-item Hamilton Depression Rating Scale Score (HAM-D)
Hide Description The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
Time Frame 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.
Arm/Group Title Testosterone Gel Placebo Gel
Hide Arm/Group Description:
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Placebo gel identical in appearance to the testosterone gel
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.5  (7.1) 15.6  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone Gel, Placebo Gel
Comments Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.
Method mixed effects linear regression analysis
Comments [Not Specified]
2.Secondary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description 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).
Time Frame 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.
Arm/Group Title Testosterone Gel Placebo Gel
Hide Arm/Group Description:
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
Placebo gel identical in appearance to the testosterone gel
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.9  (9.0) 19.9  (8.4)
Time Frame Adverse events were assessed at all study visits throughout the eight-week blinded phase of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone Gel Placebo Gel
Hide Arm/Group Description AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily Placebo gel identical in appearance to the testosterone gel
All-Cause Mortality
Testosterone Gel Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Gel Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Testosterone Gel Placebo Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      0/50 (0.00%)    
Nervous system disorders     
headache *  3/50 (6.00%)  3 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
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
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