- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00272584
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Panoramica dello studio
Descrizione dettagliata
Subjects may be inpatients or outpatients. All subjects will be treated throughout the study with clozapine, at a dose of 400 mg or more, unless limited by side effects. After screening, subjects will be augmented with placebo for 7 days. Any subject with a reduction in PANSS total score of 20% or greater will be discontinued from the study. Beginning on day 8, subjects will be randomized to continued augmentation of clozapine with placebo, or to augmentation with risperidone. The initial daily dose of risperidone will be 1.0 mg, increased in 1.0 mg increments to a total of 3.0 mg/day over a two week period. Subjects unable to tolerate at least one tablet of study medication will be dropped from the study. At the end of 8 weeks following randomization, at the choice of the investigator, open-label risperidone augmentation can be started.
The primary outcome measure is the PANSS total score at week 9. Subjects will be classified as responders if the improvement in PANSS total score is 20% or greater, and the proportion of responders in each group will be determined. Complementary outcome measures will be the CGI severity score, CGI improvement score, and SOFAS score. Safety and tolerance will be assessed by reports of adverse events and clinically significant changes in vital signs, weight, waist circumference, extrapyramidal side effects, metabolic and hematological measures.
Tipo di studio
Iscrizione
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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British Columbia
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Vancouver, British Columbia, Canada
- UBC Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
- Treatment with clozapine is at a stable dose for at least 12 weeks. Dose must be 400 mg/day or more, unless side effects limited increase of dose.
Exclusion Criteria:
- Subjects with significant alcohol or substance abuse in the past 3 months.
- Subjects with a previous trial of risperidone augmentation of clozapine
- Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
- Subjects requiring treatment with anticonvulsants.
- Subjects with known hypersensitivity or allergy to risperidone.
- Subjects with hematological or other contraindications to continued clozapine treatment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
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Misure di risultato secondarie
Misura del risultato |
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Additional outcome measures will be: proportion of subjects with a 20% or greater reduction in PANSS total score, CGI severity score, CGI improvement score and SOFAS score.
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To assess the safety of risperidone augmentation, severity of extrapyramidal side effects, metabolic measures, and general side effects will be studied. Hematological monitoring will be carried out.
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To determine if risperidone augmentation has effects on cognition, a neuropsychological test battery will be carried out.
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The predictive value of neurocognitive testing, and DNA analysis for results of risperidone augmentation will be studied.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: William Honer, MD, University of British Columbia
Pubblicazioni e link utili
Pubblicazioni generali
- Honer WG, Thornton AE, Chen EY, Chan RC, Wong JO, Bergmann A, Falkai P, Pomarol-Clotet E, McKenna PJ, Stip E, Williams R, MacEwan GW, Wasan K, Procyshyn R; Clozapine and Risperidone Enhancement (CARE) Study Group. Clozapine alone versus clozapine and risperidone with refractory schizophrenia. N Engl J Med. 2006 Feb 2;354(5):472-82. doi: 10.1056/NEJMoa053222.
- Thornton AE, Procyshyn RM, Barr AM, MacEwan GW, Honer WG. Cognition and Plasma Ratio of Clozapine to N-desmethylclozapine in Patients With Clozapine-Resistant Schizophrenia. Am J Psychiatry. 2015 Dec;172(12):1259. doi: 10.1176/appi.ajp.2015.15070899. No abstract available.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Spettro della schizofrenia e altri disturbi psicotici
- Schizofrenia
- Disturbi psicotici
- Disordini mentali
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti antipsicotici
- Agenti tranquillanti
- Psicofarmaci
- Agenti serotoninergici
- Agenti dopaminergici
- Antagonisti della serotonina
- Antagonisti della dopamina
- Risperidone
Altri numeri di identificazione dello studio
- C0-0280
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .