Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
調査の概要
詳細な説明
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.
Objectives:
Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.
Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over 12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and non-VA health service use and related costs, e) medication side effects, f) violent behavior, g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Tuscaloosa、Alabama、アメリカ、35404
- VA Medical Center, Tuscaloosa
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California
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Long Beach、California、アメリカ、90822
- VA Medical Center, Long Beach
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Palo Alto、California、アメリカ、94304-1290
- VA Palo Alto Health Care System
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Health Care System (West Haven)
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Florida
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Miami、Florida、アメリカ、33125
- VA Medical Center, Miami
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Georgia
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Augusta、Georgia、アメリカ、30904
- VA Medical Center, Augusta
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Illinois
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Chicago、Illinois、アメリカ、60612
- Jesse Brown VAMC (WestSide Division)
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Massachusetts
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Boston、Massachusetts、アメリカ、02130
- VA Medical Center, Jamaica Plain Campus
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Michigan
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Detroit、Michigan、アメリカ、48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis、Minnesota、アメリカ、55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City、Missouri、アメリカ、64128
- VA Medical Center, Kansas City MO
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Nebraska
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Omaha、Nebraska、アメリカ、68105-1873
- VA Medical Center, Omaha
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New Mexico
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Albuquerque、New Mexico、アメリカ、87108-5153
- New Mexico VA Health Care System, Albuquerque
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New York
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New York、New York、アメリカ、10010
- New York Harbor HCS
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Ohio
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Cleveland、Ohio、アメリカ、44106
- VA Medical Center, Cleveland
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- VA Medical Center, Philadelphia
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Texas
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Houston、Texas、アメリカ、77030
- Michael E. DeBakey VA Medical Center (152)
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Waco、Texas、アメリカ、76711
- Central Texas Veterans Health Care System - Waco
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Washington
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Seattle、Washington、アメリカ、98108
- VA Puget Sound Health Care System, Seattle
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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:
- Age 18 years or older.
- Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).
Patients should
- have been hospitalized in the two years before study entry on a psychiatric inpatient unit, or
- document explicit current evidence of increased use of outpatient services such as additional visits, day treatment or non-hospital residential treatment, increased dosage of medications or addition of concomitant psychotropic medications.
The b criterion will promptly be adjudicated by the study chairmen on a case-by case basis to insure credibility.
- .Adequate transportation is available and the participant lives within a travel time of less than 1.5 hours, allowing attendance at all scheduled visits.
- Use of an acceptable method of birth control by female patients who have a possibility of becoming pregnant (safety concerns).
- Able to demonstrate decisional capacity in order to give informed consent as assessed by the MacArthur Competence Assessment Tool (MacCAT) (Appelbaum and Grisso, 1996). Guardian consent is acceptable where applicable.
- Dually diagnosed patients with both schizophrenia and addictive disorders would be included in this study but should not be in need of acute detoxification for physiologic substance dependence (excluding nicotine) in the past 30 days.
Exclusion Criteria:
- Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion).
- Intolerance of risperidone.
- Intolerance of intramuscular injection.
- Current treatment with depot antipsychotic medication.
- Current treatment with oral clozapine or presence of refractory schizophrenia that, in the treating psychiatrist's opinion, requires clozapine.
- Hepatic or renal problems AST or ALT (>2 times upper limit of normal);
- Elevated bilirubin (>1.2), BUN (>24), creatinine (>1.7).
- Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care.
- Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.
- Unstable living arrangements or not planning to remain in the area for the next year.
- Legal entanglements or pending legal charges with potential of incarceration.
- Assault or suicide gesture currently needing acute intervention.
- Concurrent participation in another clinical trial with an investigational drug during the last 30 days.
- Pregnant or lactating women or women planning to become pregnant.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Arm 1
long-acting injectable risperidone
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long-acting injectable risperidone
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アクティブコンパレータ:Arm 2
oral antipsychotic medication
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doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Hospitalization-free Survival - Time to Event
時間枠:From randomization until date of first re-hospitalization, assessed up to 24 months
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A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization.
Patients without an event were censored at 24 months after the date of randomization.
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From randomization until date of first re-hospitalization, assessed up to 24 months
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Hazard Ratio for Hospitalization
時間枠:24 months
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Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.
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24 months
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協力者と研究者
捜査官
- スタディチェア:Robert A. Rosenheck, AB MD、VA Connecticut Health Care System (West Haven)
出版物と役立つリンク
一般刊行物
- Rosenheck RA, Krystal JH, Lew R, Barnett PG, Thwin SS, Fiore L, Valley D, Huang GD, Neal C, Vertrees JE, Liang MH; CSP 555 Research Group. Challenges in the design and conduct of controlled clinical effectiveness trials in schizophrenia. Clin Trials. 2011 Apr;8(2):196-204. doi: 10.1177/1740774510392931. Epub 2011 Jan 26.
- Rosenheck RA, Krystal JH, Lew R, Barnett PG, Fiore L, Valley D, Thwin SS, Vertrees JE, Liang MH; CSP555 Research Group. Long-acting risperidone and oral antipsychotics in unstable schizophrenia. N Engl J Med. 2011 Mar 3;364(9):842-51. doi: 10.1056/NEJMoa1005987. Erratum In: N Engl J Med. 2011 Mar 31;364(13):1281.
- Barnett PG, Scott JY, Rosenheck RA; CSP 555 Study Group. How do clinical trial participants compare to other patients with schizophrenia? Schizophr Res. 2011 Aug;130(1-3):34-9. doi: 10.1016/j.schres.2011.03.033. Epub 2011 Apr 22.
- Barnett PG, Scott JY, Krystal JH, Rosenheck RA; CSP 555 Research Group. Cost and cost-effectiveness in a randomized trial of long-acting risperidone for schizophrenia. J Clin Psychiatry. 2012 May;73(5):696-702. doi: 10.4088/JCP.11m07070.
- Thwin SS, Hermes E, Lew R, Barnett P, Liang M, Valley D, Rosenheck R. Assessment of the minimum clinically important difference in quality of life in schizophrenia measured by the Quality of Well-Being Scale and disease-specific measures. Psychiatry Res. 2013 Oct 30;209(3):291-6. doi: 10.1016/j.psychres.2013.01.016. Epub 2013 Mar 7.
- Hoblyn JC, Rosenheck RA, Leatherman S, Weil L, Lew R; CSP 555 Investigator Group. Veteran subjects willingness to participate in schizophrenia clinical trials. Psychiatr Q. 2013 Jun;84(2):209-18. doi: 10.1007/s11126-012-9240-4.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
IM risperidoneの臨床試験
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University of Illinois at Chicago完了
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National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human Services募集
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University Hospital WaterfordDePuy Synthes募集
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University of SydneyTelethon Kids Institute; Bionet Co., Ltd; Technovalia; Institute for Clinical Pathology and Medical...完了
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Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, Bangladesh終了しました
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Children's Fractures Interest Group, Denmark募集