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Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

Primary Purpose

Schizophrenia, Sensory Gating

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aripiprzole
Sponsored by
New Mexico VA Healthcare System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Psychiatry, Antipsychotic, Psychopharmacology, Clinical Trial, Open Label, Schizophrenia, Sensory Gating, Attention, Memory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New Mexico VA Healthcare SystemRecruiting

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2007
Last Updated
May 24, 2010
Sponsor
New Mexico VA Healthcare System
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00567099
Brief Title
Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
Official Title
Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
New Mexico VA Healthcare System
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Sensory Gating
Keywords
Psychiatry, Antipsychotic, Psychopharmacology, Clinical Trial, Open Label, Schizophrenia, Sensory Gating, Attention, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aripiprzole
Other Intervention Name(s)
Aripiprazole (Abilify)
Intervention Description
Dosage form, dosage, frequency and duration: Aripiprazole 5-30 mg tabs po qday x 3 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Billy Jimenez
Phone
(505) 265-1711
Ext
5117
Email
billy.jiminez@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Robin R. Douglas, MA, CCRC
Phone
(505) 265-1711
Ext
5528
Email
robin.douglas@med.va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Canive, MD
Organizational Affiliation
New Mexico VA Healthcare System / BRINM
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Mexico VA Healthcare System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Billy Jimenez
Phone
505-265-1711
Ext
5117
Email
billy.jimenez@va.gov
First Name & Middle Initial & Last Name & Degree
Robin R. Douglas, MA, CCRC
Phone
(505) 265-1711
Ext
5528
Email
robin.douglas@med.va.gov
First Name & Middle Initial & Last Name & Degree
Jose M Canive, MD

12. IPD Sharing Statement

Links:
URL
http://www.albuquerque.va.gov/
Description
The New Mexico VA Healthcare System website
URL
http://www.brinm.org
Description
The website for the Biomedical Research Institute of New Mexico which helps administers the funds for this project

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Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

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