Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

NCT ID: NCT00222807

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder Delusional Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Association for Geriatric Psychiatry

OTHER

Sponsor Role collaborator

Janssen Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ripu D Jindal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0306110

Identifier Type: -

Identifier Source: org_study_id

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