Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Schizophrenia Clinical Trial

Official title:

Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00567099
• Other study ID #: 0059
• Secondary ID: BRINM #150
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2007
• Last updated: May 24, 2010
• Start date: August 2003
• Est. completion date: September 2008

Study information

• Verified date: December 2007
• Source: New Mexico VA Healthcare System
• Contact: Billy Jimenez
• Phone: (505) 265-1711
• Email: billy.jiminez[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Sensory Gating

Intervention

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

Locations

Country	Name	City	State
United States	New Mexico VA Healthcare System	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico VA Healthcare System	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   The New Mexico VA Healthcare System website
•   The website for the Biomedical Research Institute of New Mexico which helps administers the funds for this project
•   The website for the University of New Mexico Human Research Review Committee which oversees the protection of human subjects for this project.