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 because the information has not been verified recently.
Verified February 2009 by Universita di Verona.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Universita di Verona
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00395915
First received: November 3, 2006
Last updated: February 17, 2009
Last verified: February 2009
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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 4 |
| 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:
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 More Information
Additional Information:
No publications provided by Universita di Verona
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 May 23, 2013