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The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00816907
First received: January 2, 2009
Last updated: February 13, 2013
Last verified: November 2010
History of Changes
Results First Received: January 3, 2013  
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: Schizophrenia
Interventions: Drug: Metformin
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
A randomized, double-blind, placebo-controlled multicenter trial conducted between March 2009 and February 2010 at 17 academic, veterans affairs, and private research clinics. 146 clinically stable overweight outpatients with chronic schizophrenia and schizoaffective disorder were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization prospective participants were screened for eligibility

Reporting Groups
  Description
Placebo Matching over-encapsulated placebo pills
Metformin Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated

Participant Flow:   Overall Study
    Placebo     Metformin  
STARTED     71     75  
COMPLETED     58     58  
NOT COMPLETED     13     17  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching over-encapsulated placebo pills
Metformin Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Total Total of all reporting groups

Baseline Measures
    Placebo     Metformin     Total  
Number of Participants  
[units: participants]
 		  71     75     146  
Age  
[units: years]
Mean ± Standard Deviation 		  45.0  ± 10.3     41.4  ± 11.5     43.2  ± 11.1  
Gender  
[units: participants]
 		     
Female     22     23     45  
Male     49     52     101  



  Outcome Measures
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1.  Primary:   Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo   [ Time Frame: Measured at the last study visit ]
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2.  Secondary:   Change in Total Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
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3.  Secondary:   Change in HDL Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
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4.  Secondary:   Change in LDL Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
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5.  Secondary:   Change in Triglycerides From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
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6.  Secondary:   Change in Fasting Glucose From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
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7.  Secondary:   Change in Fasting Insulin From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change in Hemoglobin A1c From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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
Changes over periods of more than 16 weeks are unknown.  


Results Point of Contact:  
Name/Title: Dr. Scott Stroup
Organization: Columbia University
phone: 212-543-5676
e-mail: stroups@nyspi.columbia.edu


No publications provided by National Institute of Mental Health (NIMH)

Publications automatically indexed to this study:


Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00816907     History of Changes
Other Study ID Numbers: N01 MH090001-03, N01MH90001 DSIR AT
Study First Received: January 2, 2009
Results First Received: January 3, 2013
Last Updated: February 13, 2013
Health Authority: United States: Federal Government