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Metformin for Weight Loss in Schizophrenia

This study has been terminated.
(PI moved to different institution. Decided to concentrate on different studies.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177709
First Posted: August 9, 2010
Last Update Posted: September 1, 2017
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.
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
  Purpose
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Condition Intervention
Schizophrenia Obesity Drug: Metformin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:

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


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

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


Enrollment: 12
Study Start Date: May 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
Criteria

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


Locations
United States, New York
Manhatan Psychiatric Center
New York, New York, United States, 10035
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Investigators
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 Submitted: April 23, 2010
First Posted: August 9, 2010
Results First Submitted: December 15, 2016
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:
schizophrenia
antipsychotics
obesity
diabetes

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