Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Aug 2003
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 3, 2007
CompletedFirst Posted
Study publicly available on registry
December 4, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMay 25, 2010
December 1, 2007
December 3, 2007
May 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Dosage form, dosage, frequency and duration: Aripiprazole 5-30 mg tabs po qday x 3 months
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New Mexico VA Healthcare Systemlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose M Canive, MD
New Mexico VA Healthcare System / BRINM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
December 3, 2007
First Posted
December 4, 2007
Study Start
August 1, 2003
Study Completion
September 1, 2008
Last Updated
May 25, 2010
Record last verified: 2007-12