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Metformin for Weight Loss in Schizophrenia

This study has been terminated.
(PI moved to differetnt6 institution. Decided to concentrate on different studies.)
Sponsor:
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT01177709
First received: April 23, 2010
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Weight in lbs. [ Time Frame: baseline, 4 wks, 8 wks, 12 weeks ] [ Designated as safety issue: No ]
    Patients weight in pounds


Secondary Outcome Measures:
  • Glucose levels [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Fasting glucose

  • Insulin Level [ Time Frame: baseline, 4 weks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    fasting serum insulin

  • Glucose tolerance test restuls [ Time Frame: baseline and 3 months(12 weeks) ] [ Designated as safety issue: No ]
    glucose and insulin levels from 75 gm glucose tolerance test at baseline and 3 months

  • cognitive function on memory tests [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
    scores on two cognitive tests RBANS and spatial and letter span section form MATRICS battery

  • cognitive function on memory tests [ Time Frame: baseline and 3 months ( 12 weeks) ] [ Designated as safety issue: No ]
    scores on two cognitive tests RBANS and spatial and letter span section form MATRICS battery


Enrollment: 15
Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 23, 2010
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nathan Kline Institute for Psychiatric Research:
schizophrenia
antipsychotics
obesity
diabetes

Additional relevant MeSH terms:
Obesity
Schizophrenia
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
 Metformin
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013