Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Not Applicable

• Conditions: Schizophrenia; Sensory Gating

• Registration Number: NCT00567099
• Lead Sponsor: New Mexico VA Healthcare System

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

Study Timeline

• Study Start: 2003-08
• Status Verified: 2007-12
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Study Completion: 2008-09
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month.	MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole

Trial Locations

Locations (1)

New Mexico VA Healthcare System; 🇺🇸 Albuquerque, New Mexico, United States