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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Taipei、台湾、100
- Department of Psychiatry, National Taiwan University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Treatment efficacy was assessed using PNASS, Clinical Global Impression (CGI) Scale, and EPS rating scales
時間枠：on days 0, 7, 14, 28, 56
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on days 0, 7, 14, 28, 56
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二次結果の測定
結果測定 |
時間枠 |
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HPLC analysis Genotyping
時間枠：on days 0, 14, 56
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on days 0, 14, 56
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協力者と研究者
協力者
捜査官
- スタディチェア：Tzung-Jeng Hwang, MD、Department of Psychiatry, National Taiwan University Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 200705030M
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