| Property | Value |
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linkedct:acronym
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CHAT
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linkedct:brief_title
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Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia
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linkedct:condition
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<http://data.linkedct.org/resource/condition/11790>
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linkedct:criteria
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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).
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linkedct:download_date
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Information obtained from ClinicalTrials.gov on December 30, 2009
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linkedct:eligibility_gender
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Both
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linkedct:eligibility_healthy_volunteers
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No
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linkedct:eligibility_maximum_age
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N/A
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linkedct:eligibility_minimum_age
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18 Years
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linkedct:end_date
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December 2009
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linkedct:enrollment
|
106
(xsd:int)
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linkedct:firstreceived_date
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November 3, 2006
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linkedct:has_dmc
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Yes
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linkedct:id
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NCT00395915
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rdfs:label
|
Trial NCT00395915
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linkedct:lastchanged_date
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February 17, 2009
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linkedct:lead_sponsor_agency
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<http://data.linkedct.org/resource/agency/2845>
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linkedct:location
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<http://data.linkedct.org/resource/location/80165>
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linkedct:nct_id
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NCT00395915
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linkedct:number_of_arms
|
0
(xsd:int)
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linkedct:number_of_groups
|
0
(xsd:int)
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linkedct:official_title
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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.
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linkedct:org_study_id
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2006-004708-38
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linkedct:overall_official
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<http://data.linkedct.org/resource/overall_official/41649>
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linkedct:overall_status
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Active, not recruiting
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linkedct:oversight
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<http://data.linkedct.org/resource/oversight/1550>
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linkedct:oversight
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<http://data.linkedct.org/resource/oversight/1592>
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linkedct:oversight
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<http://data.linkedct.org/resource/oversight/1601>
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foaf:page
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<http://clinicaltrials.gov/show/NCT00395915>
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linkedct:phase
|
Phase 4
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linkedct:primary_completion_date
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March 2009
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linkedct:primary_outcomes
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<http://data.linkedct.org/resource/primary_outcomes/26207>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/104995>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/107950>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/117800>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/133528>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/133530>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/13634>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/30733>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/30734>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/34654>
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linkedct:secondary_outcomes
|
<http://data.linkedct.org/resource/secondary_outcomes/6657>
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linkedct:secondary_outcomes
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<http://data.linkedct.org/resource/secondary_outcomes/66732>
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linkedct:source
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Universita di Verona
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linkedct:start_date
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September 2006
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linkedct:study_design
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Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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linkedct:study_type
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Interventional
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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.
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rdf:type
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linkedct:trials
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linkedct:verification_date
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February 2009
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