Clinical trial NCT00567099: Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
Official title: Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Sensory Gating
Keywords: Psychiatry
Antipsychotic
Psychopharmacology
Clinical Trial
Open Label
Schizophrenia
Sensory Gating
Attention
Memory
Lead sponsor: New Mexico VA Healthcare System
Sponsor class: FED
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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.
timeFrame: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
Study officials:
affiliation: New Mexico VA Healthcare System / BRINM
name: Jose M Canive, MD
role: PRINCIPAL_INVESTIGATOR
References: