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Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222807
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 22, 2005
Last Update Posted Date August 28, 2017
Study Start Date August 2003
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
Official Title Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
Brief Summary

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.

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples are collected, stored at minus 70 degree C and analyzed in batches.
Sampling Method Probability Sample
Study Population Patients with psychosis
Condition
  • Schizophrenia
  • Schizoaffective Disorder
  • Delusional Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2011)
200
Original Enrollment
 (submitted: September 19, 2005)
120
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00222807
Other Study ID Numbers 0306110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators
  • American Association for Geriatric Psychiatry
  • Janssen Pharmaceuticals
Investigators
Principal Investigator: Ripu D Jindal, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2016