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Trial NCT00395915

Resource URI: http://data.linkedct.org/resource/trials/NCT00395915
PropertyValue
linkedct:acronym CHAT
linkedct:brief_title Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia
linkedct:condition <http://data.linkedct.org/resource/condition/11790>
linkedct:criteria Inclusion Criteria: 1. Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria). 2. Treatment with clozapine for at least six months at a stable dose of 400 mg or more per day, unless the size of the dose was limited by side-effects. 3. Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis) 4. Age 18 and above. 5. Agreement between investigator and patient to enter the study. 6. The patient is normally resident in Italy. 7. It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol. 8. Uncertainty about which trial treatment would be best for the participant. 9. No medical disorder or condition contraindicates either of the investigational drugs. 10. Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2009
linkedct:enrollment 106 (xsd:int)
linkedct:firstreceived_date November 3, 2006
linkedct:has_dmc Yes
linkedct:id NCT00395915
rdfs:label Trial NCT00395915
linkedct:lastchanged_date February 17, 2009
linkedct:lead_sponsor_agency <http://data.linkedct.org/resource/agency/2845>
linkedct:location <http://data.linkedct.org/resource/location/80165>
linkedct:nct_id NCT00395915
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia. An Independent, Pragmatic, Multicentre, Parallel-Group, Superiority Trial.
linkedct:org_study_id 2006-004708-38
linkedct:overall_official <http://data.linkedct.org/resource/overall_official/41649>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://data.linkedct.org/resource/oversight/1550>
linkedct:oversight <http://data.linkedct.org/resource/oversight/1592>
linkedct:oversight <http://data.linkedct.org/resource/oversight/1601>
foaf:page <http://clinicaltrials.gov/show/NCT00395915>
linkedct:phase Phase 4
linkedct:primary_completion_date March 2009
linkedct:primary_outcomes <http://data.linkedct.org/resource/primary_outcomes/26207>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/104995>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/107950>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/117800>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/133528>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/133530>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/13634>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/30733>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/30734>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/34654>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/6657>
linkedct:secondary_outcomes <http://data.linkedct.org/resource/secondary_outcomes/66732>
linkedct:source Universita di Verona
linkedct:start_date September 2006
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The principal clinical question to be answered by CHAT (Clozapine Haloperidol Aripiprazole Trial) is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared to combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time.
rdf:type linkedct:trials
linkedct:verification_date February 2009