- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00132314
Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Tuscaloosa, Alabama, États-Unis, 35404
- VA Medical Center, Tuscaloosa
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California
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Long Beach, California, États-Unis, 90822
- VA Medical Center, Long Beach
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Palo Alto, California, États-Unis, 94304-1290
- VA Palo Alto Health Care System
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Connecticut
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West Haven, Connecticut, États-Unis, 06516
- VA Connecticut Health Care System (West Haven)
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Florida
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Miami, Florida, États-Unis, 33125
- VA Medical Center, Miami
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Georgia
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Augusta, Georgia, États-Unis, 30904
- VA Medical Center, Augusta
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Jesse Brown VAMC (WestSide Division)
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Massachusetts
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Boston, Massachusetts, États-Unis, 02130
- VA Medical Center, Jamaica Plain Campus
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Michigan
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Detroit, Michigan, États-Unis, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, États-Unis, 64128
- VA Medical Center, Kansas City MO
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Nebraska
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Omaha, Nebraska, États-Unis, 68105-1873
- VA Medical Center, Omaha
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87108-5153
- New Mexico VA Health Care System, Albuquerque
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New York
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New York, New York, États-Unis, 10010
- New York Harbor HCS
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- VA Medical Center, Cleveland
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- VA Medical Center, Philadelphia
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Texas
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Houston, Texas, États-Unis, 77030
- Michael E. DeBakey VA Medical Center (152)
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Waco, Texas, États-Unis, 76711
- Central Texas Veterans Health Care System - Waco
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Washington
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Seattle, Washington, États-Unis, 98108
- VA Puget Sound Health Care System, Seattle
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Arm 1
long-acting injectable risperidone
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long-acting injectable risperidone
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hospitalization-free Survival - Time to Event
Délai: 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.
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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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Robert A. Rosenheck, AB MD, VA Connecticut Health Care System (West Haven)
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Spectre de la schizophrénie et autres troubles psychotiques
- La schizophrénie
- Troubles psychotiques
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents tranquillisants
- Médicaments psychotropes
- Agents de sérotonine
- Agents dopaminergiques
- Antagonistes de la sérotonine
- Antagonistes de la dopamine
- Rispéridone
- Agents antipsychotiques
Autres numéros d'identification d'étude
- 555
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