Metformin for Weight Loss in Schizophrenia

Overview[ - collapse ][ - ]

Purpose Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.
ConditionSchizophrenia
Obesity
InterventionDrug: Metformin
PhaseN/A
SponsorNathan Kline Institute for Psychiatric Research
Responsible PartyNathan Kline Institute for Psychiatric Research
ClinicalTrials.gov IdentifierNCT01177709
First ReceivedApril 23, 2010
Last UpdatedMay 16, 2012
Last verifiedMay 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 23, 2010
Last Updated DateMay 16, 2012
Start DateMay 2000
Estimated Primary Completion DateApril 2011
Current Primary Outcome MeasuresWeight in lbs. [Time Frame: baseline, 4 wks, 8 wks, 12 weeks] [Designated as safety issue: No]Patients weight in pounds
Current 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

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin for Weight Loss in Schizophrenia
Official TitleEvaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication
Brief Summary
Study hypothesis is that patients on antipsychotics medication treated with metformin will
show loss in weight and improved measures of glucose metabolism.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Schizophrenia
  • Obesity
InterventionDrug: Metformin
metformin 500- 2500 mg/day.
Study Arm (s)Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment15
Estimated Completion DateApril 2011
Estimated Primary Completion DateApril 2011
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01177709
Other Study ID Numbers091/C22
Has Data Monitoring CommitteeNo
Information Provided ByNathan Kline Institute for Psychiatric Research
Study SponsorNathan Kline Institute for Psychiatric Research
CollaboratorsNot Provided
Investigators Not Provided
Verification DateMay 2012

Locations[ + expand ][ + ]

Manhatan Psychiatric Center
New York, New York, United States, 10035