Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

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	Complete list of historical versions of study NCT00222807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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	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 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; (submitted: February 16, 2011)	200
Original Enrollment; (submitted: September 19, 2005)	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