Status:
UNKNOWN
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia
Lead Sponsor:
Universita di Verona
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 co...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria).
- 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.
- Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
- Age 18 and above.
- Agreement between investigator and patient to enter the study.
- The patient is normally resident in Italy.
- It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
- Uncertainty about which trial treatment would be best for the participant.
- No medical disorder or condition contraindicates either of the investigational drugs.
- Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00395915
Start Date
September 1 2006
End Date
December 1 2009
Last Update
February 18 2009
Active Locations (1)
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1
University of Verona
Verona, Italy, 37124