Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222807
First received: September 13, 2005
Last updated: February 16, 2011
Last verified: February 2011
  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: Observational Model: Case Control
Time Perspective: 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

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


Estimated Enrollment: 200
Study Start Date: August 2003
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Alicia A Thomas, 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: Ripu Jindal, MD Clinical Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222807     History of Changes
Other Study ID Numbers: 0306110
Study First Received: September 13, 2005
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014