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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
Sponsor:
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
  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


  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 ]

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

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 (46.48%)   40/75 (53.33%) 
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 
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

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