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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

Study Description
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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.


Condition or disease
Schizophrenia Schizoaffective Disorder Delusional Disorder

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 Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
Study Start Date : August 2003
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples Without DNA
blood samples are collected, stored at minus 70 degree C and analyzed in batches.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with psychosis
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222807


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
American Association for Geriatric Psychiatry
Janssen Pharmaceuticals
Investigators
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Principal Investigator: Ripu D Jindal, MD University of Pittsburgh
More Information
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00222807    
Other Study ID Numbers: 0306110
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: March 2016
Keywords provided by University of Pittsburgh:
schizophrenia, psychosis, type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Disease
Schizophrenia
Psychotic Disorders
Schizophrenia, Paranoid
Pathologic Processes
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders