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

This study is ongoing, but not recruiting participants.

First Received: May 22, 2006 Last Updated: April 7, 2008 History of Changes

Sponsors and Collaborators:	Seoul National University Hospital Hallym University Medical Center Gachon University Gil Medical Center
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00328952

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

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia

Further study details as provided by Seoul National University Hospital:

Enrollment:	40
Study Start Date:	August 2004
Estimated Study Completion Date:	August 2008

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:	No

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:

Click here for detailed information about the experience of hearing voices. This link exits the ClinicalTrials.gov site

Click here for the information about approaches to hallucination control in schizophrenia. This link exits the ClinicalTrials.gov site

Publications:

Shergill SS, Murray RM, McGuire PK. Auditory hallucinations: a review of psychological treatments. Schizophr Res. 1998 Aug 17;32(3):137-50. Review.

Farhall J, Gehrke M. Coping with hallucinations: exploring stress and coping framework. Br J Clin Psychol. 1997 May;36 ( Pt 2):259-61.

Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89.

Nayani TH, David AS. The auditory hallucination: a phenomenological survey. Psychol Med. 1996 Jan;26(1):177-89.

Study ID Numbers:	KYS-2006-05018
Study First Received:	May 22, 2006
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00328952 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

schizophrenia
auditory verbal hallucination
antipsychotic treatment

Study placed in the following topic categories:

Tranquilizing Agents
Hallucinations
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Schizophrenia
Signs and Symptoms

Mental Disorders
Neurologic Manifestations
Psychotic Disorders
Neurobehavioral Manifestations
Perceptual Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Hallucinations
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Signs and Symptoms
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents
Neurobehavioral Manifestations
Perceptual Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009