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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 National Clinical Trials Identifier (NCT ID):

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:	University of Verona ( Corrado Barbui MD )
Study ID Numbers:	2006-004708-38
Study First Received:	November 3, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00395915 History of Changes
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:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Haloperidol
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Aripiprazole
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents

Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010