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Schizophrenia | Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Sensory Gating

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AripiprzoleDosage form, dosage, frequency and duration: Aripiprazole 5-30 mg tabs po qday x 3 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: August 2003

Completed Date: September 2008

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Jose M Canive, MD

Lead Sponsor: New Mexico VA Healthcare System

Collaborator: Bristol-Myers Squibb

More information:https://clinicaltrials.gov/show/NCT00567099

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