Oculomotor and Spatial Cognition Deficits in Schizophrenia
This study has been terminated.
(Study was terminated due to low accrual.)
Information provided by (Responsible Party):
Jeffrey R. Bishop, University of Illinois
First received: June 25, 2009
Last updated: January 23, 2013
Last verified: January 2013
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Clinical and Computational Studies of Dopamine Function in Schizophrenia
Primary Outcome Measures:
- Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.
We will be assessing clinical symptoms and cognition before and after treatment.
|Ages Eligible for Study:
||15 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931996
|UIC Center for Cognitive Medicine
|Chicago, Illinois, United States, 60612 |
University of Illinois at Chicago
||John A Sweeney, PhD
No publications provided
||Jeffrey R. Bishop, Assistant Professor, University of Illinois
History of Changes
|Other Study ID Numbers:
||2001-0522, R01MH062134, R01MH080066
|Study First Received:
||June 25, 2009
|Results First Received:
||November 8, 2011
||January 23, 2013
||United States: Institutional Review Board
Keywords provided by University of Illinois at Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents