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

This study has been completed.
Sponsor:
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
  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

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)
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.

  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 April 17, 2014