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Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

This study is currently recruiting participants.
Verified by New Mexico VA Healthcare System, December 2007

Sponsors and Collaborators: New Mexico VA Healthcare System
Bristol-Myers Squibb
Information provided by: New Mexico VA Healthcare System
ClinicalTrials.gov Identifier: NCT00567099
  Purpose

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 Intervention
Schizophrenia
Sensory Gating
Drug: Aripiprzole

MedlinePlus related topics:   Schizophrenia   

ChemIDplus related topics:   Aripiprazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:   Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Further study details as provided by New Mexico VA Healthcare System:

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. [ Time Frame: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole ] [ Designated as safety issue: No ]

Estimated Enrollment:   20
Study Start Date:   August 2003
Estimated Study Completion Date:   September 2008

Intervention Details:
    Drug: Aripiprzole

    Dosage form, dosage, frequency and duration:

    Aripiprazole 5-30 mg tabs po qday x 3 months

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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567099

Contacts
Contact: Billy Jimenez     (505) 265-1711 ext 5117     billy.jiminez@va.gov    
Contact: Robin R. Douglas, MA, CCRC     (505) 265-1711 ext 5528     robin.douglas@med.va.gov    

Locations
United States, New Mexico
New Mexico VA Healthcare System     Recruiting
      Albuquerque, New Mexico, United States, 87108
      Contact: Billy Jimenez     505-265-1711 ext 5117     billy.jimenez@va.gov    
      Contact: Robin R. Douglas, MA, CCRC     (505) 265-1711 ext 5528     robin.douglas@med.va.gov    
      Principal Investigator: Jose M Canive, MD            

Sponsors and Collaborators
New Mexico VA Healthcare System
Bristol-Myers Squibb

Investigators
Principal Investigator:     Jose M Canive, MD     New Mexico VA Healthcare System / BRINM    
  More Information


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

Responsible Party:   New Mexico VA Healthcare System ( Jose M. Canive, MD )
Study ID Numbers:   0059, BRINM #150
First Received:   December 3, 2007
Last Updated:   December 12, 2007
ClinicalTrials.gov Identifier:   NCT00567099
Health Authority:   United States: Federal Government

Keywords provided by New Mexico VA Healthcare System:
Psychiatry  
Antipsychotic  
Psychopharmacology  
Clinical Trial  
Open Label  
Schizophrenia
Sensory Gating
Attention
Memory

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Aripiprazole
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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