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Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
This study is currently recruiting participants.
Verified by University of Pittsburgh, November 2008
First Received: September 13, 2005   Last Updated: November 5, 2008   History of Changes
Sponsor: University of Pittsburgh
Collaborators: 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

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

Resource links provided by NLM:


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: 150
Study Start Date: August 2003
Estimated Study Completion Date: December 2009
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

No publications provided

Responsible Party: University of Pittsburgh ( Ripu Jindal, MD Clinical Assistant Professor )
Study ID Numbers: 0306110
Study First Received: September 13, 2005
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00222807     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Disease
Metabolic Diseases
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Diabetes Mellitus
Central Nervous System Depressants
Endocrine System Diseases
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Schizophrenia, Paranoid
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Glucose Metabolism Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2009