Status:
COMPLETED
Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Hallym University Medical Center
Gachon University Gil Medical Center
Conditions:
Schizophrenia
Hallucinations
Eligibility:
All Genders
15-65 years
Brief Summary
The purpose of this study is to evaluate the changes in various aspects of auditory verbal hallucinations during 24-week antipsychotic treatment in naturalistic condition.
Detailed Description
Auditory verbal hallucinations (AVH), meaning the experience of hearing voices, occur in 60-75% of patients with schizophrenia. Patients experiencing persistent AVH tend to be interrupted in their dai...
Eligibility Criteria
Inclusion
- Male or female patients, 15-65 years of age
- Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)\>
- Patients experiencing vivid AVH confirmed by score of 4 or above using hallucinatory behavior item on Positive And Negative Syndrome Scale (PANSS).
- Patients who are drug-naive or drug-free for more than 4 weeks.
- Patients who are scheduled to receive atypical antipsychotic medication.
- Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
- Subjects who are fluent in Korean.
Exclusion
- DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
- Mental retardation (IQ \< 70).
- Neurological disorders including epilepsy, stroke, or severe head trauma.
- Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
- Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline.
- History of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months.
- Subjects who are not fluent in Korean.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00328952
Start Date
August 1 2004
End Date
August 1 2008
Last Update
September 16 2009
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744