Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 16, 2011

Start Date ^ICMJE

August 2003

Estimated Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00222807 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Official Title ^ICMJE

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

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Schizophrenia
Schizoaffective Disorder
Delusional Disorder

Intervention ^ICMJE

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 ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

June 2014

Estimated Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00222807

Other Study ID Numbers ^ICMJE

0306110

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Ripu Jindal, MD Clinical Assistant Professor, University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

American Association for Geriatric Psychiatry
Janssen Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Ripu D Jindal, MD

University of Pittsburgh

PRS Account

University of Pittsburgh

Verification Date

February 2011

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

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