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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
Enrollment 146

Recruitment Details 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 Prior to randomization prospective participants were screened for eligibility
Arm/Group Title Placebo Metformin
Hide Arm/Group Description Matching over-encapsulated placebo pills Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Period Title: Overall Study
Started 71 75
Completed 58 58
Not Completed 13 17
Arm/Group Title Placebo Metformin Total
Hide Arm/Group Description Matching over-encapsulated placebo pills Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated Total of all reporting groups
Overall Number of Baseline Participants 71 75 146
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 75 participants 146 participants
45.0  (10.3) 41.4  (11.5) 43.2  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 75 participants 146 participants
Female
22
  31.0%
23
  30.7%
45
  30.8%
Male
49
  69.0%
52
  69.3%
101
  69.2%
1.Primary Outcome
Title Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable population that took assigned study treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
Matching over-encapsulated placebo pills
Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
Overall Number of Participants Analyzed 71 75
Mean (95% Confidence Interval)
Unit of Measure: kilograms
-1.0
(-2.0 to -0.0)
-3.0
(-4.0 to -2.0)
2.Secondary Outcome
Title Change in Total Cholesterol From Baseline to 16 Weeks
Hide Description Total cholesterol
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
randomized participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
0.2
(-6.5 to 6.9)
-8.9
(-15.6 to -2.3)
3.Secondary Outcome
Title Change in HDL Cholesterol From Baseline to 16 Weeks
Hide Description high-density lipoprotein
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
randomized participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.4
(-2.3 to 1.4)
-0.6
(-2.4 to 1.2)
4.Secondary Outcome
Title Change in LDL Cholesterol From Baseline to 16 Weeks
Hide Description low-density lipoprotein
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-2.0
(-7.7 to 3.7)
-7.1
(-12.6 to -1.5)
5.Secondary Outcome
Title Change in Triglycerides From Baseline to 16 Weeks
Hide Description serum triglycerides
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
13.2
(-0.3 to 26.7)
-7.0
(-20.4 to 6.3)
6.Secondary Outcome
Title Change in Fasting Glucose From Baseline to 16 Weeks
Hide Description fasting blood glucose
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-1.6
(-4.3 to 1.2)
-2.3
(-5.0 to 0.5)
7.Secondary Outcome
Title Change in Fasting Insulin From Baseline to 16 Weeks
Hide Description Fasting insulin
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Mean (95% Confidence Interval)
Unit of Measure: mU/L
5.5
(-1.7 to 12.6)
1.6
(-5.5 to 8.6)
8.Secondary Outcome
Title Change in Hemoglobin A1c From Baseline to 16 Weeks
Hide Description glycosylated hemoglobin
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants who took assigned treatment
Arm/Group Title Placebo Metformin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 71 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
0.01
(-0.04 to 0.06)
-0.06
(-0.11 to -0.01)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Metformin
Hide Arm/Group Description Matching over-encapsulated placebo pills Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
All-Cause Mortality
Placebo Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/71 (9.86%)      3/75 (4.00%)    
Cardiac disorders     
rule-out myocardial infarction *  1/71 (1.41%)  1 0/75 (0.00%)  0
myocardial infarction *  1/71 (1.41%)  1 0/75 (0.00%)  0
Gastrointestinal disorders     
abdominal pain *  1/71 (1.41%)  1 0/75 (0.00%)  0
Musculoskeletal and connective tissue disorders     
elective knee-surgery *  1/71 (1.41%)  1 0/75 (0.00%)  0
Nervous system disorders     
rule-out seizure *  0/71 (0.00%)  0 1/75 (1.33%)  1
Psychiatric disorders     
Suicidality *  1/71 (1.41%)  1 1/75 (1.33%)  1
Exacerbation of schizophrenia *  2/71 (2.82%)  2 0/75 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pneumonia *  0/71 (0.00%)  0 1/75 (1.33%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/71 (46.48%)      40/75 (53.33%)    
Gastrointestinal disorders     
diarrhea   12/71 (16.90%)  12 25/75 (33.33%)  25
nausea   8/71 (11.27%)  8 12/75 (16.00%)  12
abdominal discomfort   9/71 (12.68%)  9 12/75 (16.00%)  12
vomiting   3/71 (4.23%)  3 8/75 (10.67%)  8
Musculoskeletal and connective tissue disorders     
Muscle pain   10/71 (14.08%)  10 13/75 (17.33%)  13
weakness   6/71 (8.45%)  6 8/75 (10.67%)  8
Nervous system disorders     
headache   17/71 (23.94%)  17 11/75 (14.67%)  11
Indicates events were collected by systematic assessment
Changes over periods of more than 16 weeks are unknown.
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.
Results Point of Contact
Name/Title: Dr. Scott Stroup
Organization: Columbia University
Phone: 212-543-5676
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 ( Other Identifier: National Institute of Mental Health )
First Submitted: January 2, 2009
First Posted: January 5, 2009
Results First Submitted: January 3, 2013
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013