Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia - Full Text View

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00395915

Purpose

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	Intervention	Phase
Schizophrenia	Drug: aripiprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Aripiprazole Clozapine

U.S. FDA Resources

Further study details as provided by Universita di Verona:

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.

Enrollment:	106
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395915

Locations

Italy
University of Verona
Verona, Italy, 37124

Sponsors and Collaborators

Universita di Verona

Investigators

Study Chair:

Michele Tansella, MD

University of Verona

More Information

Additional Information:

Click here for more information about the CHAT study This link exits the ClinicalTrials.gov site

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Barbui C, Accordini S, Nosè 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.

Nosè 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, Mulè S, Nicholau S, Nosè 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, Saraò 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.

Responsible Party:	Corrado Barbui MD, University of Verona
ClinicalTrials.gov Identifier:	NCT00395915 History of Changes
Other Study ID Numbers:	2006-004708-38
Study First Received:	November 3, 2006
Last Updated:	February 17, 2009
Health Authority:	Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency

Keywords provided by Universita di Verona:

schizophrenia
antipsychotics
treatment non response
pragmatic trial

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Haloperidol
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on February 09, 2012