- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00272584
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada
- UBC Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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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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Sekundære resultatmål
Resultatmål |
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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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: William Honer, MD, University of British Columbia
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Skizofrenispektrum og andre psykotiske lidelser
- Skizofreni
- Psykotiske lidelser
- Psykiske lidelser
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Dopaminmidler
- Serotonin-antagonister
- Dopamin-antagonister
- Risperidon
Andre undersøgelses-id-numre
- C0-0280
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