Back to resultsOculomotor and Spatial Cognition Deficits in Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antipsychotic
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, antipsychotic, risperidone
Eligibility Criteria
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.
Sites / Locations
- UIC Center for Cognitive Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antipsychotic
Arm Description
Antipsychotic
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00931996
First Posted
June 25, 2009
Last Updated
January 23, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00931996
Brief Title
Oculomotor and Spatial Cognition Deficits in Schizophrenia
Official Title
Clinical and Computational Studies of Dopamine Function in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to low accrual.
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
We will be assessing clinical symptoms and cognition before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, antipsychotic, risperidone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antipsychotic
Arm Type
Experimental
Arm Description
Antipsychotic
Intervention Type
Drug
Intervention Name(s)
Antipsychotic
Intervention Description
Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Sweeney, PhD
Organizational Affiliation
UIC/UTSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIC Center for Cognitive Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oculomotor and Spatial Cognition Deficits in Schizophrenia
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