Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by New Mexico VA Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00567099
First received: December 3, 2007
Last updated: May 24, 2010
Last verified: December 2007
  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

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

  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
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 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

Additional Information:
No publications provided

Responsible Party: Jose M. Canive, MD, New Mexico VA Healthcare System
ClinicalTrials.gov 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:
Psychiatry
Antipsychotic
Psychopharmacology
Clinical Trial
Open Label
Schizophrenia
Sensory Gating
Attention
Memory

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014