Clinical trial NCT00328952: Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
Official title: Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Hallucinations
Keywords: schizophrenia
auditory verbal hallucination
antipsychotic treatment
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
name: Gachon University Gil Medical Center
First posted: 2006-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: voice-hearing patients with schizophrenia

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Gachon University Gil Medical Center
name: Jong-Hoon Kim, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hallym University Medical Center
name: Jung Seo Yi, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Shergill SS, Murray RM, McGuire PK. Auditory hallucinations: a review of psychological treatments. Schizophr Res. 1998 Aug 17;32(3):137-50. doi: 10.1016/s0920-9964(98)00052-8.
citation: Farhall J, Gehrke M. Coping with hallucinations: exploring stress and coping framework. Br J Clin Psychol. 1997 May;36(2):259-61. doi: 10.1111/j.2044-8260.1997.tb01411.x.
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. doi: 10.1017/s0033291799008661.
citation: Nayani TH, David AS. The auditory hallucination: a phenomenological survey. Psychol Med. 1996 Jan;26(1):177-89. doi: 10.1017/s003329170003381x.