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Oculomotor and Spatial Cognition Deficits in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00931996
Recruitment Status : Terminated (Study was terminated due to low accrual.)
First Posted : July 2, 2009
Results First Posted : January 24, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeffrey R. Bishop, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Antipsychotic Not Applicable

Detailed Description:
We will be assessing clinical symptoms and cognition before and after treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical and Computational Studies of Dopamine Function in Schizophrenia
Study Start Date : June 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Antipsychotic
Antipsychotic
Drug: Antipsychotic
Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.



Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline. [ Time Frame: Baseline and 6 weeks ]
    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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Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931996


Locations
United States, Illinois
UIC Center for Cognitive Medicine
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: John A Sweeney, PhD UIC/UTSW

Responsible Party: Jeffrey R. Bishop, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00931996     History of Changes
Other Study ID Numbers: 2001-0522
R01MH062134 ( U.S. NIH Grant/Contract )
R01MH080066 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2009    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Jeffrey R. Bishop, University of Illinois at Chicago:
schizophrenia
antipsychotic
risperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents