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NCT00222807 Clinical Trial

Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Schizophrenia Clinical Trial

Official title:
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222807
Other study ID # 0306110
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated August 25, 2017
Start date August 2003
Est. completion date March 2016

Study information
Verified date March 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)
Lead Sponsor Collaborator
University of Pittsburgh American Association for Geriatric Psychiatry, Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

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