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Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by New Mexico VA Healthcare System.
Recruitment status was:  Recruiting
Bristol-Myers Squibb
Information provided by:
New Mexico VA Healthcare System Identifier:
First received: December 3, 2007
Last updated: May 24, 2010
Last verified: December 2007
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
Sensory Gating
Drug: Aripiprzole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Resource links provided by NLM:

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

    Other Name: Aripiprazole (Abilify)
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00567099

United States, New Mexico
New Mexico VA Healthcare System
Albuquerque, New Mexico, United States, 87108
Sponsors and Collaborators
New Mexico VA Healthcare System
Bristol-Myers Squibb
Principal Investigator: Jose M Canive, MD New Mexico VA Healthcare System / BRINM
  More Information

Additional Information:
Responsible Party: Jose M. Canive, MD, New Mexico VA Healthcare System Identifier: NCT00567099     History of Changes
Other Study ID Numbers: 0059  BRINM #150 
Study First Received: December 3, 2007
Last Updated: May 24, 2010
Health Authority: United States: Federal Government

Keywords provided by New Mexico VA Healthcare System:
Clinical Trial
Open Label
Sensory Gating

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on January 18, 2017