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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00816907
Recruitment Status : Completed
First Posted : January 5, 2009
Results First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):

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

  Participant Flow

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
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

  Outcome Measures

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 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Change in Triglycerides From Baseline to 16 Weeks
Measure Description serum triglycerides
Time Frame 16 weeks  

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.
participants who took assigned treatment

Reporting Groups
Placebo No text entered.
Metformin No text entered.

Measured Values
   Placebo   Metformin 
Participants Analyzed 
[Units: Participants]
 71   75 
Change in Triglycerides From Baseline to 16 Weeks 
[Units: mg/dL]
Least Squares Mean (95% Confidence Interval)
 (-0.3 to 26.7) 
 (-20.4 to 6.3) 

No statistical analysis provided for Change in Triglycerides From Baseline to 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

  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.

  More Information