Recruiting

Aripiprazole

Sponsor:

New Mexico VA Healthcare System

Code:

NCT00567099

Conditions

Schizophrenia

Sensory Gating

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Aripiprzole

Study Details

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.

Conditions

Schizophrenia

Sensory Gating

Study ID

NCT00567099

Start date

Aug, 2003

Status verified date

Dec, 2007

Completion date

Sep, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Aripiprzole

Dosage form, dosage, frequency and duration:

Aripiprazole 5-30 mg tabs po qday x 3 months

Primary outcome 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. [ Time Frame: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole ]

Central Contacts and Locations

Central contacts

Billy Jimenez

(505) 265-1711billy.jiminez@va.gov

Robin R. Douglas, MA, CCRC

(505) 265-1711robin.douglas@med.va.gov

Locations

New Mexico VA Healthcare System

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Billy Jimenez

505-265-1711billy.jimenez@va.gov

Robin R. Douglas, MA, CCRC

(505) 265-1711robin.douglas@med.va.gov

Principal Investigator:

Jose M Canive, MD

More Information

Sponsor

New Mexico VA Healthcare System

Last update posted

May 25, 2010

Last verified

Dec, 2007

Keywords

  • Psychiatry
  • Antipsychotic
  • Psychopharmacology
  • Clinical Trial
  • Open Label
  • Schizophrenia
  • Sensory Gating
  • Attention
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New Mexico VA Healthcare System on 2010-05-25.