Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborators:
Hallym University Medical Center
Gachon University Gil Medical Center
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00328952
First received: May 22, 2006
Last updated: September 15, 2009
Last verified: September 2009
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Purpose
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.
| Condition |
|---|
|
Schizophrenia Hallucinations |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Biospecimen Retention: Samples Without DNA
Detailed Description:
routine lab tests for changes in medical condition
| Enrollment: | 40 |
| Study Start Date: | August 2004 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
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 daily routines and have trouble keeping regular jobs due to the intrusiveness or abusive contents of voices. In addition, auditory hallucinations are reported to remain even after disappearance of other psychotic symptoms in many patients with schizophrenia spectrum disorders after treatment with typical antipsychotics.
The study involves detailed phenomenological assessments of AVH and other psychotic symptoms, as well as side effects of atypical antipsychotics.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
voice-hearing patients with schizophrenia
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328952
Locations
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Seoul National University Hospital
Hallym University Medical Center
Gachon University Gil Medical Center
Investigators
| Study Director: | Jong-Hoon Kim, MD, PhD | Gachon University Gil Medical Center |
| Study Director: | Jung Seo Yi, MD, PhD | Hallym University Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Yong Min Ahn/Associate Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT00328952 History of Changes |
| Other Study ID Numbers: | KYS-2006-05018 |
| Study First Received: | May 22, 2006 |
| Last Updated: | September 15, 2009 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Seoul National University Hospital:
|
schizophrenia auditory verbal hallucination antipsychotic treatment |
Additional relevant MeSH terms:
|
Hallucinations Schizophrenia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013