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

Schizophrenia Clinical Trial

Official title:

Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328952
• Other study ID #: KYS-2006-05018
• Status: Completed
• Phase: N/A
• First received: May 22, 2006
• Last updated: September 15, 2009
• Start date: August 2004
• Est. completion date: August 2008

Study information

• Verified date: September 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Gachon University Gil Medical Center, Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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

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. — View Citation

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

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

External Links

•   Click here for the information about approaches to hallucination control in schizophrenia.