Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 28, 2017
March 1, 2016
12.6 years
September 13, 2005
August 25, 2017
Conditions
Keywords
Eligibility Criteria
Patients with psychosis
You may qualify if:
- Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association
You may not qualify if:
- Diabetes, type 1 or 2
- Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use)
- Age above 50 or age below 14
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- American Association for Geriatric Psychiatrycollaborator
- Janssen Pharmaceuticalscollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Biospecimen
blood samples are collected, stored at minus 70 degree C and analyzed in batches.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ripu D Jindal, MD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
August 1, 2003
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 28, 2017
Record last verified: 2016-03