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

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ClinicalTrials.gov Identifier: NCT00816907
Recruitment Status : Completed
First Posted : January 5, 2009
Results First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)

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
  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

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 
Overall Participants Analyzed 
[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

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 ]
  Hide Outcome Measure 1

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  

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 
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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change in Total Cholesterol From Baseline to 16 Weeks
Measure Description Total cholesterol
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.
randomized participants who took assigned treatment

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

Measured Values
   Placebo   Metformin 
Participants Analyzed 
[Units: Participants]
 		 71   75 
Change in Total Cholesterol From Baseline to 16 Weeks 
[Units: mg/dL]
Mean (95% Confidence Interval) 		 0.2 
 (-6.5 to 6.9)  		 -8.9 
 (-15.6 to -2.3) 

No statistical analysis provided for Change in Total Cholesterol From Baseline to 16 Weeks



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

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

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

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

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


  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