- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00328952
Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Patients With Schizophrenia
Naturalistic Multicenter Study of Changes in Auditory Verbal Hallucination During Atypical Antipsychotic Treatment of Schizophrenia
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Seoul, 대한민국, 110-744
- Seoul National University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
공동 작업자 및 조사자
수사관
- 연구 책임자: Jong-Hoon Kim, MD, PhD, Gachon University Gil Medical Center
- 연구 책임자: Jung Seo Yi, MD, PhD, Hallym University Medical Center
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- Nayani TH, David AS. The auditory hallucination: a phenomenological survey. Psychol Med. 1996 Jan;26(1):177-89. doi: 10.1017/s003329170003381x.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .