- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00132314
Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
Alabama
-
Tuscaloosa, Alabama, Spojené státy, 35404
- VA Medical Center, Tuscaloosa
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California
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Long Beach, California, Spojené státy, 90822
- VA Medical Center, Long Beach
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Palo Alto, California, Spojené státy, 94304-1290
- VA Palo Alto Health Care System
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Connecticut
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West Haven, Connecticut, Spojené státy, 06516
- VA Connecticut Health Care System (West Haven)
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Florida
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Miami, Florida, Spojené státy, 33125
- VA Medical Center, Miami
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Georgia
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Augusta, Georgia, Spojené státy, 30904
- VA Medical Center, Augusta
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Jesse Brown VAMC (WestSide Division)
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02130
- VA Medical Center, Jamaica Plain Campus
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Michigan
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Detroit, Michigan, Spojené státy, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, Spojené státy, 64128
- VA Medical Center, Kansas City MO
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Nebraska
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Omaha, Nebraska, Spojené státy, 68105-1873
- VA Medical Center, Omaha
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87108-5153
- New Mexico VA Health Care System, Albuquerque
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New York
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New York, New York, Spojené státy, 10010
- New York Harbor HCS
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Ohio
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Cleveland, Ohio, Spojené státy, 44106
- VA Medical Center, Cleveland
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- VA Medical Center, Philadelphia
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Texas
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Houston, Texas, Spojené státy, 77030
- Michael E. DeBakey VA Medical Center (152)
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Waco, Texas, Spojené státy, 76711
- Central Texas Veterans Health Care System - Waco
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Washington
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Seattle, Washington, Spojené státy, 98108
- VA Puget Sound Health Care System, Seattle
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Arm 1
long-acting injectable risperidone
|
long-acting injectable risperidone
|
Aktivní komparátor: Arm 2
oral antipsychotic medication
|
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Hospitalization-free Survival - Time to Event
Časové okno: From randomization until date of first re-hospitalization, assessed up to 24 months
|
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.
|
From randomization until date of first re-hospitalization, assessed up to 24 months
|
Hazard Ratio for Hospitalization
Časové okno: 24 months
|
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.
|
24 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Robert A. Rosenheck, AB MD, VA Connecticut Health Care System (West Haven)
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Duševní poruchy
- Schizofrenní spektrum a jiné psychotické poruchy
- Schizofrenie
- Psychotické poruchy
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Uklidňující prostředky
- Psychotropní drogy
- Serotoninové látky
- Dopaminové látky
- Antagonisté serotoninu
- Antagonisté dopaminu
- Risperidon
- Antipsychotické látky
Další identifikační čísla studie
- 555
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