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
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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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
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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Measure Type Primary
Measure Title Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo
Measure Description Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)
Time Frame Measured at the last study visit  
Safety Issue No  

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.
Evaluable population that took assigned study treatment

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

Measured Values
    Placebo     Metformin  
Number of Participants Analyzed  
[units: participants]
  71     75  
Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo  
[units: kilograms]
Mean ( 95% Confidence Interval )
  -1.0  
  ( -2.0 to -0.0 )  
  -3.0  
  ( -4.0 to -2.0 )  

No statistical analysis provided for Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo



2.  Secondary:   Change in Total Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

3.  Secondary:   Change in HDL Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

4.  Secondary:   Change in LDL Cholesterol From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

5.  Secondary:   Change in Triglycerides From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

6.  Secondary:   Change in Fasting Glucose From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

7.  Secondary:   Change in Fasting Insulin From Baseline to 16 Weeks   [ Time Frame: 16 weeks ]

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
    Placebo     Metformin  
Total, serious adverse events      
# participants affected / at risk     7/71 (9.86%)     3/75 (4.00%)  
Cardiac disorders      
rule-out myocardial infarction *    
# participants affected / at risk     1/71 (1.41%)     0/75 (0.00%)  
# events     1     0  
myocardial infarction *    
# participants affected / at risk     1/71 (1.41%)     0/75 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
abdominal pain *    
# participants affected / at risk     1/71 (1.41%)     0/75 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
elective knee-surgery *    
# participants affected / at risk     1/71 (1.41%)     0/75 (0.00%)  
# events     1     0  
Nervous system disorders      
rule-out seizure *    
# participants affected / at risk     0/71 (0.00%)     1/75 (1.33%)  
# events     0     1  
Psychiatric disorders      
Suicidality *    
# participants affected / at risk     1/71 (1.41%)     1/75 (1.33%)  
# events     1     1  
Exacerbation of schizophrenia *    
# participants affected / at risk     2/71 (2.82%)     0/75 (0.00%)  
# events     2     0  
Respiratory, thoracic and mediastinal disorders      
pneumonia *    
# participants affected / at risk     0/71 (0.00%)     1/75 (1.33%)  
# events     0     1  
* Events were collected by non-systematic assessment




  Other Adverse Events


  Limitations and Caveats
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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.


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