Oculomotor and Spatial Cognition Deficits in Schizophrenia

NCT00931996 | Terminated Results

• 3 other identifiers: 2001-0522R01MH062134R01MH080066
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; antipsychotic; risperidone

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks

Study Arms (1)

Antipsychotic

EXPERIMENTAL

Antipsychotic

Drug: Antipsychotic

Interventions

Antipsychotic DRUG

Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.

Antipsychotic

Eligibility Criteria

• Age: 15 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UIC Center for Cognitive Medicine

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Jeffrey Bishop
• Organization: Ullinois

jbishop@uic.edu

312-413-3495

Study Officials

• John A Sweeney, PhD

  UIC/UTSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 24, 2013
• Results First Posted: January 24, 2013

Record last verified: 2013-01

Locations

US (1)