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Completed

NCT Number: NCT00328952

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

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.

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Gachon University Gil Medical Center
  • Hallym University Medical Center

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
May 24, 2006
Registry last updated
Sep 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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