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Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00395915
Acronym
CHAT
Enrollment
106
Registered
2006-11-06
Start date
2006-09-30
Completion date
2009-12-31
Last updated
2009-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, antipsychotics, treatment non response, pragmatic trial

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 compared to combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time.

Interventions

DRUGaripiprazole

Sponsors

Universita di Verona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Withdrawal from allocated treatment within 3 months.

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026