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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
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


  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 ]

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


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

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Placebo     Metformin  
Total, other (not including serious) adverse events      
# participants affected / at risk     33/71     40/75  
Gastrointestinal disorders      
diarrhea    
# participants affected / at risk     12/71 (16.90%)     25/75 (33.33%)  
# events     12     25  
nausea    
# participants affected / at risk     8/71 (11.27%)     12/75 (16.00%)  
# events     8     12  
abdominal discomfort    
# participants affected / at risk     9/71 (12.68%)     12/75 (16.00%)  
# events     9     12  
nausea    
# participants affected / at risk     8/71 (11.27%)     12/75 (16.00%)  
# events     8     12  
vomiting    
# participants affected / at risk     3/71 (4.23%)     8/75 (10.67%)  
# events     3     8  
Musculoskeletal and connective tissue disorders      
Muscle pain    
# participants affected / at risk     10/71 (14.08%)     13/75 (17.33%)  
# events     10     13  
weakness    
# participants affected / at risk     6/71 (8.45%)     8/75 (10.67%)  
# events     6     8  
Nervous system disorders      
headache    
# participants affected / at risk     17/71 (23.94%)     11/75 (14.67%)  
# events     17     11  
Events were collected by systematic assessment



  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.


  More Information