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

Sponsor

Universita di Verona (Other)

Overall Status

Unknown status

CT.gov ID

NCT00395915

Collaborator

(none)

106

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: aripiprazole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Sep 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Withdrawal from allocated treatment within 3 months. []

Secondary Outcome Measures

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 adjunctive medication 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. []
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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).