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Metformin for Weight Loss in Schizophrenia

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: NCT01177709
Recruitment Status : Terminated (PI moved to different institution. Decided to concentrate on different studies.)
First Posted : August 9, 2010
Results First Posted : February 7, 2017
Last Update Posted : September 1, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Condition or disease Intervention/treatment
Schizophrenia Obesity Drug: Metformin

Detailed Description:
Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication
Study Start Date : May 2008
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Metformin Drug: Metformin
metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.

Outcome Measures

Primary Outcome Measures :
  1. Weight (wt) in Pounds (Lbs).. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
    Patients weight in pounds

Secondary Outcome Measures :
  1. Glucose Levels [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
    Fasting glucose

  2. Insulin Level [ Time Frame: baseline, 4 weks, 8 weeks, 12 weeks ]
    fasting serum insulin uIU/ml.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients will be 18-70 years of age;
  • Currently hospitalized or an outpatient at MPC;
  • BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
  • Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

  • Age below 18 or over 70;
  • Patient is currently already treated with metformin.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177709

United States, New York
Manhatan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Principal Investigator: Robert C. Smith, MD PHD Nathan Kline Institute for Psychiatric Research
More Information

Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist-Principal investigator, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT01177709     History of Changes
Other Study ID Numbers: 091/C22
First Posted: August 9, 2010    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:

Additional relevant MeSH terms:
Weight Loss
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs