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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00328952 |
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Date of registration:
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22/05/2006 |
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Primary sponsor: |
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Public title:
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Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
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Scientific title:
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Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00328952 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jong-Hoon Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gachon University Gil Medical Center |
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Name:
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Jung Seo Yi, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hallym University Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
15 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hallucinations
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Schizophrenia
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Secondary ID(s)
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KYS-2006-05018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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