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Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborators:
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00222807
First received: September 13, 2005
Last updated: August 25, 2017
Last verified: March 2016
History of Changes
September 13, 2005
August 25, 2017
August 2003
March 2016   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00222807 on ClinicalTrials.gov Archive Site
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Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

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.

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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
blood samples are collected, stored at minus 70 degree C and analyzed in batches.
Probability Sample
Patients with psychosis
  • Schizophrenia
  • Schizoaffective Disorder
  • Delusional Disorder
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 50 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00222807
0306110
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
  • American Association for Geriatric Psychiatry
  • Janssen Pharmaceuticals
Principal Investigator: Ripu D Jindal, MD University of Pittsburgh
University of Pittsburgh
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP