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

Schizophrenia Clinical Trial

— CHAT  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00395915
• Other study ID #: 2006-004708-38
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 3, 2006
• Last updated: February 17, 2009
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2009
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• aripiprazole

Locations

Country	Name	City	State
Italy	University of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

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

External Links

•   Click here for more information about the CHAT study