Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Th… (NCT00631722) | Clinical Trial Compass
CompletedNot Applicable
Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia
80 participantsStarted 2007-05
Plain-language summary
This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic agent-haloperidol, in treating acute schizophrenia episode and to evaluate the effect of the effectiveness of acute schizophrenia episode on long-term tolerability.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Written informed consent provided by legal guardians and/or patients.
✓. Age from 18-60 years old (inclusion), male or female, inpatients or outpatients.
✓. A diagnosis of schizophrenia by ICD-10 criteria as F20.0, F20.1, F20.2 and F20.3.
✓. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
✓. Able to understand and comply with the requirements of the study.
✓. PANSS total score at least 60 with EC factor score at least 15 at both screening and randomisation.
Exclusion criteria
✕. Pregnancy or lactation.
✕. Diagnosis of other mental disorders including mood disorder, schizoform disorder, schizoaffective disorder, delusional disorder, transient psychotic disorder etc.
✕. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
✕. Known intolerance or lack of response to quetiapine fumarate and haloperidol, as judged by the investigator.
✕. Known lack of response to clozapine, as judged by the investigator.
✕. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
What they're measuring
1
To evaluate the onset of action quetiapine fumarate (seroquel) in the treatment of Chinese schizophrenic patient with agitation compared with haloperidol by the analysis of time to reduction of PANSS-EC by 20 %
✕. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids.
✕. Within one dosing interval for long acting antipsychoticsUse.