- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00931996
Oculomotor and Spatial Cognition Deficits in Schizophrenia
January 23, 2013 updated by: Jeffrey R. Bishop, University of Illinois at Chicago
Clinical and Computational Studies of Dopamine Function in Schizophrenia
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia.
However, the regional disturbances in brain function causing these deficits are not yet known.
This application proposes a series of integrated behavioral studies designed to identify causes of deficits in schizophrenia.
Study Overview
Detailed Description
We will be assessing clinical symptoms and cognition before and after treatment.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- UIC Center for Cognitive Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 64 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion Criteria: Inclusion criteria for this study are (1) able and willing to give written informed consent; (2) no contraindications to MRI (cardiac pacemaker, aneurysm clip, cochlear implants, IUD, shrapnel, history of metal fragments in eyes, neurostimulators or other metal devices, weight of 250lbs or more, claustrophobia) and (3) medically stable. Sedation will not be used for MRI studies because cooperation is essential.
Exclusion Criteria:
- Any subject is excluded from the imaging studies if they have any contraindications to MRI such as cardiac pacemaker, aneurysm clip, cochlear implants, pregnancy in the later stages (because of body size and limited comfort for MRI studies), IUD, shrapnel, history of metal fragments in eyes, neurostimulators, weight of 250 lbs. or more, or claustrophobia. Individuals with mental retardation, neurologic disease or significant medical illness that might effect neuronal or vascular physiology will not be recruited.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Antipsychotic
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Risperidone is the first line antipsychotic followed by others per clinician choice.
Flexible dosing QD x 4-6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
Time Frame: Baseline and 6 weeks
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Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers.
PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms.
A positive change score (baseline-6 weeks) indicates an improvement in symptoms.
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Baseline and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John A Sweeney, PhD, UIC/UTSW
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
June 25, 2009
First Submitted That Met QC Criteria
July 1, 2009
First Posted (Estimate)
July 2, 2009
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 23, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001-0522
- R01MH062134 (U.S. NIH Grant/Contract)
- R01MH080066 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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