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Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight

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ClinicalTrials.gov Identifier: NCT00834652
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Sertraline
Drug: Metformin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sertraline Plus Metformin

Participants will receive sertraline and metformin for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Sertraline Plus Placebo

Participants will receive sertraline and placebo for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day


Participant Flow:   Overall Study
    Sertraline Plus Metformin   Sertraline Plus Placebo
STARTED   104   102 
COMPLETED   66   62 
NOT COMPLETED   38   40 



  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
Sertraline Plus Metformin

Participants will receive sertraline and metformin for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Metformin: Starting dose of 500 mg daily and increasing by 500 mg every 2 weeks to a total of 2,000 mg daily

Sertraline Plus Placebo

Participants will receive sertraline and placebo for 16 weeks.

Sertraline: 50 mg once a day, which may be increased to 200 mg once a day

Total Total of all reporting groups

Baseline Measures
   Sertraline Plus Metformin   Sertraline Plus Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 104   102   206 
Age 
[Units: Years]
Mean (Full Range)
 43.67 
 (20 to 60) 
 42.15 
 (22 to 58) 
 42.91 
 (20 to 60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      86  82.7%      85  83.3%      171  83.0% 
Male      18  17.3%      17  16.7%      35  17.0% 
Region of Enrollment 
[Units: Participants]
     
United States   104   102   206 
Marital Status (married) 
[Units: Participants]
 48   45   93 
Education 
[Units: Years]
Mean (Full Range)
 14.64 
 (10 to 18) 
 14.60 
 (8 to 20) 
 14.62 
 (8 to 20) 
Baseline Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Full Range)
 38.53 
 (27.44 to 59.23) 
 38.07 
 (27.80 to 58.42) 
 38.30 
 (27.44 to 59.23) 


  Outcome Measures

1.  Primary:   Change of Beck Depression Inventory-II Scores Over 16 Weeks   [ Time Frame: Measured at Baseline and 16 Weeks ]


  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
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  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: Patrick J. Lustman, Ph.D.
Organization: Washington University School of Medicine
phone: 3142861320
e-mail: lustmanp@psychiatry.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00834652     History of Changes
Other Study ID Numbers: R01MH081150 ( U.S. NIH Grant/Contract )
R01MH081150 ( U.S. NIH Grant/Contract )
DAHBR 96-BHC
First Submitted: February 2, 2009
First Posted: February 3, 2009
Results First Submitted: August 8, 2016
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018