Role of Anti-Inflammatory Agents in Patients With Schizophrenia
Study of Role of Anti-Inflammatory Agents in Patients With Schizophrenia
There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Cox-2 inhibitors have been tested in preliminary clinical trials for schizophrenia and depression, showing favourable effects compared to placebo (Muller and Schwarz et al 2009).
Statins were introduced as cholesterol-lowering agents but have found much wider usage. They are anti-inflammatory agents and thus similar to the Cox-2 inhibitors, which have shown some ability as adjuncts to improve the symptoms of schizophrenia in preliminary studies. The statins are also known to decrease C-reactive protein (CRP), which has been shown in an SMRI-funded study to be elevated in a study of individuals with schizophrenia. Fan et al (2007) demonstrated in a small study in patients with schizophrenia that higher than normal levels of CRP (>0.50 mg/dl) was associated with marked negative symptoms and higher total PANSS scores.
Ondansetron is a serotonin (5-HT3) receptor antagonist that is generic and widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. GSK did a small study on it as an antipsychotic in the 1980s. Since then, several small studies have suggested that it is effective as an adjunct drug in improving the symptoms of schizophrenia.
Statins are widely used in schizophrenia sufferers, particularly those taking second generation antipsychotics, to treat hypercholesterolemia. Both drugs are well tolerated and their side effect profiles well understood.
We propose to conduct a feasibility study in patients with chronic schizophrenia to explore the adjunct use of simvastatin and ondansetron on positive, negative and general psychopathology in comparisons to treatment as usual (TAU) over a 12 week period.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Karachi、パキスタン
- Dow University of Health Sciences
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Karachi、パキスタン
- Karwan e hayat
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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:
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
- competent and willing to give informed consent
- stable on medication 4 weeks prior to baseline
- able to take oral medication and likely to complete the required evaluations
- female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication.
Exclusion Criteria:
- Relevant medical illness [renal and hepatic] in the opinion of the investigators
- history of high alcohol intake
- any change of psychotropic medications within the previous six weeks
- diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
- pregnant or breast-feeding.
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 |
---|---|
プラセボコンパレーター:プラセボ
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TAUにプラセボを追加
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アクティブコンパレータ:シンバスタチン
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TAUにシンバスタチンを追加 シンバスタチン20mgを1日1回服用
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アクティブコンパレータ:オンダンセトロン
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オンダンセトロンを TAU に追加 オンダンセトロンは 8mg を 1 日 1 回投与
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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 |
---|---|
acceptability and tolerability of simvastatin and ondansetron added to TAU
時間枠:3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
simvastatin and ondansetron added to TAU prevents the accumulation of negative symptoms in patients with schizophrenia
時間枠:3 months
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3 months
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simvastatin and ondansetron added to TAU prevents cognitive decline
時間枠:3 months
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3 months
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To compare the effect size
時間枠:3 months
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3 months
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協力者と研究者
捜査官
- 主任研究者:Imran B Chaudhry, MD、University of Manchester
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
- PILL-UoM-0110
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