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

Phase 4

• Conditions: Schizophrenia

• Registration Number: NCT00395915
• Lead Sponsor: Universita di Verona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-11-03
• Study First Submitted QC: 2006-11-03
• Study First Posted: 2006-11-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18
• Primary Completion: 2009-03
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Withdrawal from allocated treatment within 3 months.

Secondary Outcome Measures

Name	Time	Method
Concurrent use of adjunctive 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.
Withdrawal from study treatment, due to adverse reactions, within 3 and 12 months.
Concurrent use of antiparkinson medication within 3 and 12 months.
Adverse events within 3 and 12 months.
Biological parameters, measured at month 3 and 12.
Subjective tolerability of antipsychotic drugs, measured at month 3 and 12.
Deliberate self-harm within 3 and 12 months.
Metabolic syndrome within 3 and 12 months.

Trial Locations

Locations (1)

University of Verona; 🇮🇹 Verona, Italy