Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia (CHAT)
Recruitment status was Active, not recruiting
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.
|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.|
- Withdrawal from allocated treatment within 3 months.
- 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.
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395915
|University of Verona|
|Verona, Italy, 37124|
|Study Chair:||Michele Tansella, MD||Universita di Verona|