Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatment aripiprazole
Phase phase 4
Sponsor Universita di Verona
Start date September 2006
End date March 2009
Trial size 106 participants
Trial identifier NCT00395915, 2006-004708-38

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Withdrawal from allocated treatment within 3 months.
time frame:

Secondary Outcomes

Measure
Withdrawal from allocated treatment within 12 months of follow-up.
time frame:
Time to withdrawal from allocated treatment.
time frame:
Severity of illness, measured at month 3 and 12.
time frame:
Withdrawal from study treatment, due to adverse reactions, within 3 and 12 months.
time frame:
Concurrent use of adjunctive medication within 3 and 12 months.
time frame:
Concurrent use of antiparkinson medication within 3 and 12 months.
time frame:
Adverse events within 3 and 12 months.
time frame:
Biological parameters, measured at month 3 and 12.
time frame:
Metabolic syndrome within 3 and 12 months.
time frame:
Subjective tolerability of antipsychotic drugs, measured at month 3 and 12.
time frame:
Deliberate self-harm within 3 and 12 months.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Universita di Verona.