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

NCT00395915 | Unknown Phase 4 DMC

• 1 other identifier: 2006-004708-38
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; antipsychotics; treatment non response; pragmatic trial

Outcome Measures

Primary Outcomes (1)

• Withdrawal from allocated treatment within 3 months.

Secondary Outcomes (11)

• 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.

Interventions

aripiprazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

University of Verona

Verona, 37124, Italy

Location

Related Publications (3)

• Cipriani A, Accordini S, Nose M, Purgato M, Girlanda F, Tansella M, Barbui C. Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. J Clin Psychopharmacol. 2013 Aug;33(4):533-7. doi: 10.1097/JCP.0b013e318296884f.

  PMID: 23775051 DERIVED

• Barbui C, Accordini S, Nose M, Stroup S, Purgato M, Girlanda F, Esposito E, Veronese A, Tansella M, Cipriani A; CHAT (Clozapine Haloperidol Aripiprazole Trial) Study Group. Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia in routine clinical care: a randomized, controlled trial. J Clin Psychopharmacol. 2011 Jun;31(3):266-73. doi: 10.1097/JCP.0b013e318219cba3.

  PMID: 21508849 DERIVED

• Nose M, Accordini S, Artioli P, Barale F, Barbui C, Beneduce R, Berardi D, Bertolazzi G, Biancosino B, Bisogno A, Bivi R, Bogetto F, Boso M, Bozzani A, Bucolo P, Casale M, Cascone L, Ciammella L, Cicolini A, Cipresso G, Cipriani A, Colombo P, Dal Santo B, De Francesco M, Di Lorenzo G, Di Munzio W, Ducci G, Erlicher A, Esposito E, Ferrannini L, Ferrato F, Ferro A, Fragomeno N, Parise VF, Frova M, Gardellin F, Garzotto N, Giambartolomei A, Giupponi G, Grassi L, Grazian N, Grecu L, Guerrini G, Laddomada F, Lazzarin E, Lintas C, Malchiodi F, Malvini L, Marchiaro L, Marsilio A, Mauri MC, Mautone A, Menchetti M, Migliorini G, Mollica M, Moretti D, Mule S, Nicholau S, Nose F, Occhionero G, Pacilli AM, Pecchioli S, Percudani M, Piantato E, Piazza C, Pontarollo F, Pycha R, Quartesan R, Rillosi L, Risso F, Rizzo R, Rocca P, Roma S, Rossattini M, Rossi G, Rossi G, Sala A, Santilli C, Sarao G, Sarnicola A, Sartore F, Scarone S, Sciarma T, Siracusano A, Strizzolo S, Tansella M, Targa G, Tasser A, Tomasi R, Travaglini R, Veronese A, Ziero S. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia. Trials. 2009 May 15;10:31. doi: 10.1186/1745-6215-10-31.

  PMID: 19445659 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michele Tansella, MD

  Universita di Verona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2006
• First Posted: November 6, 2006
• Study Start: September 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

IT (1)