Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328952
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : September 16, 2009
Hallym University Medical Center
Gachon University Gil Medical Center
Information provided by:
Seoul National University Hospital

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.

Condition or disease
Schizophrenia Hallucinations

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 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.

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia
Study Start Date : August 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
routine lab tests for changes in medical condition

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
voice-hearing patients with schizophrenia

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328952

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
Study Director: Jong-Hoon Kim, MD, PhD Gachon University Gil Medical Center
Study Director: Jung Seo Yi, MD, PhD Hallym University Medical Center

Additional Information:
Responsible Party: Yong Min Ahn/Associate Professor, Seoul National University Hospital Identifier: NCT00328952     History of Changes
Other Study ID Numbers: KYS-2006-05018
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

Keywords provided by Seoul National University Hospital:
auditory verbal hallucination
antipsychotic treatment

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs