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Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

This study is currently recruiting participants.
Verified by University of Pittsburgh, February 2008

Sponsors and Collaborators: University of Pittsburgh
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222807
  Purpose

This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls.

Regardless the treatment status, we collect the same neuroendocrine-immune data on the participants after 2 months.


Condition
Schizophrenia
Schizoaffective Disorder
Delusional Disorder

MedlinePlus related topics:   Diabetes    Psychotic Disorders    Schizophrenia   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

blood samples are collected, stored at minus 70 degree C and analyzed in batches.


Estimated Enrollment:   120
Study Start Date:   August 2003
Estimated Study Completion Date:   December 2008

Detailed Description:

This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls.

Regardless the treatment status, we collect the same neuroendocrine-immune on the participants (patients and controls) after 2 months. Thus, our study does not control treatment. Patients take treatment in consultation with their physician. Some of them even decide not to take any medications. At the 2nd visit, we do ask them about the the medications they are taking if any.

  Eligibility
Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample

Study Population

Patients with psychosis


Criteria

Inclusion Criteria:

  • Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association

Exclusion Criteria:

  • Diabetes, type 1 or 2
  • Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use)
  • Age above 50 or age below 14
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222807

Contacts
Contact: Ripu D Jindal, MD     412 512 9516     jindalr@upmc.edu    

Locations
United States, Pennsylvania
University of Pittsburgh     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: Richard S Guido, MD     412-383-1480     guidrs@upmc.edu    
      Principal Investigator: Ripu D Jindal, MD            
      Sub-Investigator: Matcheri S Keshavan, MD            
      Sub-Investigator: Kevin Eklund, BSN            
      Sub-Investigator: Govner Thorp, BS            

Sponsors and Collaborators
University of Pittsburgh
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals

Investigators
Principal Investigator:     Ripu D Jindal, MD     University of Pittsburgh    
  More Information


Responsible Party:   University of Pittsburgh ( Ripu Jindal, MD Clinical Assistant Professor )
Study ID Numbers:   0306110
First Received:   September 13, 2005
Last Updated:   February 21, 2008
ClinicalTrials.gov Identifier:   NCT00222807
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
schizophrenia, psychosis, type 2 diabetes mellitus  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Schizophrenia
Schizophrenia, Paranoid
Delusions
Mental Disorders
Diabetes Mellitus, Type 2
Psychotic Disorders
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 03, 2008




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