Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia (CHAT)
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|ClinicalTrials.gov Identifier: NCT00395915|
Recruitment Status : Unknown
Verified February 2009 by Universita di Verona.
Recruitment status was: Active, not recruiting
First Posted : November 6, 2006
Last Update Posted : February 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: aripiprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||December 2009|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395915
|University of Verona|
|Verona, Italy, 37124|
|Study Chair:||Michele Tansella, MD||Universita di Verona|