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Effects of Testosterone in Women With Depression

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ClinicalTrials.gov Identifier: NCT00676676
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Drug: Testosterone
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Testosterone
Hide Arm/Group Description Testosterone Patch 300mcg replaced every 3-4 days
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Testosterone
Hide Arm/Group Description Testosterone Patch 300mcg replaced every 3-4 days
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
48.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Scale
Hide Description the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).
Time Frame Baseline, 2-week, 8-week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This was a pilot protocol
Arm/Group Title Testosterone
Hide Arm/Group Description:
Testosterone Patch 300mcg replaced every 3-4 days
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline visit 25.9  (4.6)
2-week visit 14.7  (8.4)
8-week visit 15.2  (10.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone
Comments Baseline versus 2-week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone
Comments Baseline versus 8-week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 8-weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone
Hide Arm/Group Description Testosterone Patch 300mcg replaced every 3-4 days
All-Cause Mortality
Testosterone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone
Affected / at Risk (%) # Events
Total   0/9 (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
Affected / at Risk (%) # Events
Total   2/9 (22.22%)    
Skin and subcutaneous tissue disorders   
erythema at testosterone patch site †  1/9 (11.11%)  1
oily skin/acne †  1/9 (11.11%)  1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Karen K. Miller
Organization: Massachusetts General Hospita
Phone: 617-726-3870
Responsible Party: Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00676676     History of Changes
Other Study ID Numbers: 2007p000348
First Submitted: May 8, 2008
First Posted: May 13, 2008
Results First Submitted: May 10, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012