Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

NCT ID: NCT00567099

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia prior to initiation with aripiprazole treatment and after three months of taking the antipsychotic medication aripiprazole.

Detailed Description

Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuroimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of aripiprzole on sensory gating. Subjects who meet all inclusion criteria will receive a clinical interview, an MRI, MEG, and neuropsychological testing before starting treatment with aripiprazole and again 3 months later to determine if patients with schizophrenia who are treated with aripiprazole will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating

Conditions

Schizophrenia; Sensory Gating

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Aripiprzole

Dosage form, dosage, frequency and duration:

Aripiprazole 5-30 mg tabs po qday x 3 months

Intervention Type: DRUG

Other Intervention Names

Aripiprazole (Abilify)

Eligibility Criteria

Inclusion Criteria

Patient Population

• Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
• no comorbid diagnosis of PTSD
• continuous treatment with a conventional antipsychotic, risperidone or olanzapine for at least 3 months
• absence of psychiatric hospitalization for at least 3 month
• no history of drug dependency in their lifetime
• no history of alcohol or other substance abuse in the 6 months prior to entry into the study
• no history of head injury with loss of consciousness for more than 5 minutes
• no history of seizure disorder
• no mood stabilizing agents
• between 18-65 and
• able to sign informed consent

Normal Controls

• Matched in age and gender to patient population
• No history of psychiatric dysfunction or alcohol or other substance dependence in their lifetime as determine by the SCID
• No history of alcohol or other substance abuse in the previous 6 months
• No family history of psychotic disorder in first degree relatives as assessed by the FH-RDC diagnostic interview
• No history of head injury with loss of consciousness for more than 5 minutes
• No history of seizure disorder
• Between 18-65
• Able to sign informed consent

Exclusion Criteria

Subjects will be excluded from participating in this study if they:

• Require treatment with a mood stabilizer
• Have had an inpatient hospitalization in the past 3 months\
• Have a history of a neurological disorder
• Have any other axis I diagnosis besides schizophrenia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

New Mexico VA Healthcare System

FED

Sponsor Role: lead

Responsible Party

New Mexico VA Healthcare System

Principal Investigators

Jose M Canive, MD

Role: PRINCIPAL_INVESTIGATOR

New Mexico VA Healthcare System / BRINM

Locations

New Mexico VA Healthcare System

Albuquerque, New Mexico, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Billy Jimenez

Role: CONTACT

billy.jiminez@va.gov

(505) 265-1711 ext. 5117

Robin R. Douglas, MA, CCRC

Role: CONTACT

robin.douglas@med.va.gov

(505) 265-1711 ext. 5528

Facility Contacts

Billy Jimenez

Role: primary

billy.jimenez@va.gov

505-265-1711 ext. 5117

Robin R. Douglas, MA, CCRC

Role: backup

robin.douglas@med.va.gov

(505) 265-1711 ext. 5528

Related Links

http://www.albuquerque.va.gov/

The New Mexico VA Healthcare System website

http://www.brinm.org

The website for the Biomedical Research Institute of New Mexico which helps administers the funds for this project

Other Identifiers

BRINM #150

Identifier Type: -

Identifier Source: secondary_id

0059

Identifier Type: -

Identifier Source: org_study_id