Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents
Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents: Combination of Pharmacogenomics and Therapeutic Drug Monitoring
연구 개요
상세 설명
Aripiprazole (commercial name abilify) is the first commercially available drug with dopamine partial agonist effects approved for the treatment of schizophrenia and bipolar disorder since 2002 in the U.S. It reduces negative symptoms of schizophrenia efficiently and has a markedly lower incidence of extrapyramidal symptoms and tardive dyskinesia. However, the process of switching other antipsychotic agents to aripiprazole can result in a re-emergence or worsening of psychosis, along with unpleasant side effects such as insomnia, nausea, vomiting, anxiety and agitation. On the basis of a prior study demonstrating the efficacy and safety of aripiprazole in Taiwan population, we hence propose to apply a combined use of pharmacogenomics and therapeutic drug monitoring in the evaluation of the strategies of switching stable schizophrenia patients to aripiprazole from other antipsychotic agents.
We will evaluate their cytochrome P450 background along with other potential candidate genes of schizophrenia. This 2-year proposal will examine the relative efficacy, safety and tolerability of two different strategies for switching stable inpatients/outpatients from prior antipsychotic monotherapy to aripiprazole 15 mg/day monotherapy using two different strategies:
- Fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks.
- Slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks.
A total of 200 stable schizophrenia patients will be randomized with open label to two strategies.
We expect to achieve the following results:
- Developing a protocol that has high probability of switching successfully schizophrenia patients to aripiprazole, which is effective in treatment refractory cases and has a markedly lower incidence of severe side effects, from other antipsychotics.
- Elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- Department of Psychiatry, National Taiwan University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and non-lactating, non-pregnant women who are aged 18 to 65 years
- primary diagnosis of DSM-IV schizophrenia or schizoaffective disorder
- taking a stabilized dose of a single oral antipsychotic for at least 1 month prior to study entry
- cannot have been hospitalized for an exacerbation of schizophrenia or schizoaffective disorder for at least 2 months
Exclusion Criteria:
- having other psychiatric disorders
- hospitalizing for acute exacerbation of patients' condition within 2 months
- having taken a selective serotonin reuptake inhibitor (SSRI) within 4 weeks of screening
- a first episode of schizophrenia or schizoaffective disorder
- a clinically significant neurological abnormality other than tardive dyskinesia or EPS
- current diagnosis of psychoactive substance dependence or a historical drug or alcohol abuse within 1 month before the beginning of the study
- treatment with an investigational drug within 4 weeks prior to randomization
- requiring to take medication that inhibits the microsomal enzyme CYP2D6 or inhibits or acts as a substrate for CYP3A4
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 1
fast tapering of the previous medication within 1 week after initiating aripiprazole for 2 weeks
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Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
다른 이름들:
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활성 비교기: 2
slow tapering of the previous medication within 4 weeks after initiating aripiprazole for 2 weeks
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Aripiprazole will be given as a fixed does, 15 mg/day, orally throughout 8 weeks in the 2 arms.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Treatment efficacy was assessed using PNASS, Clinical Global Impression (CGI) Scale, and EPS rating scales
기간: on days 0, 7, 14, 28, 56
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on days 0, 7, 14, 28, 56
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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HPLC analysis Genotyping
기간: on days 0, 14, 56
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on days 0, 14, 56
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공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Tzung-Jeng Hwang, MD, Department of Psychiatry, National Taiwan University Hospital
간행물 및 유용한 링크
일반 간행물
- Ma CH, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Chen WJ, Hwang TJ. Identifying dopamine supersensitivity through a randomized controlled study of switching to aripiprazole from other antipsychotic agents in patients with schizophrenia. Ther Adv Psychopharmacol. 2022 Jan 28;12:20451253211064396. doi: 10.1177/20451253211064396. eCollection 2022.
- Jen YW, Hwang TJ, Chan HY, Hsieh MH, Liu CC, Liu CM, Hwu HG, Kuo CH, Lin YT, Chien YL, Chen WJ. Abnormally low prolactin levels in schizophrenia patients after switching to aripiprazole in a randomized trial: a biomarker for rebound in psychotic symptoms? BMC Psychiatry. 2020 Nov 23;20(1):552. doi: 10.1186/s12888-020-02957-7.
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 200705030M
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