Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

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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

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

200

Original Enrollment

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

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