SchizophreniaNCT00222807
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with psychosis
Who may be able to join
- Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association
Who cannot join
- Diabetes, type 1 or 2
- Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use)
- Age above 50 or age below 14
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- Keywords
- schizophrenia, psychosis, type 2 diabetes mellitus
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Geriatric Psychiatry, Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ripu D Jindal, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222807
- Sponsor's protocol ID
- 0306110
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00222807
- Acronym / sponsor ID
- 0306110
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- Keywords
- schizophrenia, psychosis, type 2 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Association for Geriatric Psychiatry, Janssen Pharmaceuticals
- Study start
- Aug 2003
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with psychosis
Key inclusion criteria (1 listed)
- Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association
Key exclusion criteria (3 listed)
- Diabetes, type 1 or 2
- Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use)
- Age above 50 or age below 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ripu D Jindal, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.