Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Sponsor

New Mexico VA Healthcare System (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00567099

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Sensory Gating	Drug: Aripiprzole	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Study Start Date :

Aug 1, 2003

Anticipated Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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