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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Universita di Verona.
Recruitment status was:  Active, not recruiting
Information provided by:
Universita di Verona Identifier:
First received: November 3, 2006
Last updated: February 17, 2009
Last verified: February 2009
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
Drug: aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Current treatment with clozapine for the primary indication of schizophrenia (clinical diagnosis, guided by DSM-IV criteria).
  2. 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.
  3. Unsatisfactory benefit from clozapine treatment, as indicated by the presence of positive symptoms (delusions, hallucinations, abnormal behaviour, clinical diagnosis)
  4. Age 18 and above.
  5. Agreement between investigator and patient to enter the study.
  6. The patient is normally resident in Italy.
  7. It is considered clinically reasonable to try combination treatment with clozapine and aripiprazole or with clozapine and haloperidol.
  8. Uncertainty about which trial treatment would be best for the participant.
  9. No medical disorder or condition contraindicates either of the investigational drugs.
  10. Agreement between investigator and patient to discontinue any antipsychotic drugs other than clozapine (including long-acting antipsychotic drugs).
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Please refer to this study by its identifier: NCT00395915

University of Verona
Verona, Italy, 37124
Sponsors and Collaborators
Universita di Verona
Study Chair: Michele Tansella, MD Universita di Verona
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
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. doi: 10.1186/1745-6215-10-31.

Responsible Party: Corrado Barbui MD, University of Verona Identifier: NCT00395915     History of Changes
Other Study ID Numbers: 2006-004708-38
Study First Received: November 3, 2006
Last Updated: February 17, 2009

Keywords provided by Universita di Verona:
treatment non response
pragmatic trial

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents
GABA Antagonists
GABA Agents processed this record on May 25, 2017