Randomized evaluation of the effectiveness of clozapine and aripiprazole versus clozapine and haloperidol in the treatment of schizofrenia. An independent, pragmatic, multicentre, parallel-group, superiority trial. - CHAT protocol

• Conditions: Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10039636Term: Schizophrenia simple

• Registration Number: EUCTR2006-004708-38-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-15
• Last Update Posted: 23 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Current treatment with clozapine for the primary indication of schizophrenia; tratment with clozapine for at least 6 months at a stable dose of 400 mg or more per day; unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms; age 18 and above; agreement between investigator and patient to enter the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who treated with clozapine for neurological diseases; homeless patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal clinical question to be answered 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;Secondary Objective: To analize all patients included in the study in terms of outcome of psychotic symptoms, considering both randomized patients and patients included in the observational cohort.;Primary end point(s): Withdrawal from allocated treatment within 3 months of follow-up.