IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study) (NCT00136994) | Clinical Trial Compass
CompletedPhase 3
IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
Italy160 participantsStarted 2003-03
Plain-language summary
To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Psychiatric:
* Diagnosis of schizophrenia using DSM-IV (295.xx).
* Patients entering hospital (or inpatients transferring to higher-dependency unit) within the previous seven days because of acute exacerbation of psychotic symptoms.
* PANSS \> 80 (score ³ 3 on at least three of the following PANSS agitation items: anxiety , tension, hostility, excitement).
* CGI-S ³ 4. - Indication, based on intensity/severity of psychotic symptoms, on IM therapy.
* General:
* Male or Female patients aged 18-60 years at screening.
* Written informed consent to participation.
* Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception can be initiated or continued.
Exclusion Criteria:
* Psychiatric:
* Patients at immediate risk of committing harm to self or others
* Concurrent treatment with other antipsychotic agents after baseline
* Patients receiving depot antipsychotic medication within 21 days of screening
* Treatment with antidepressants or mood stabilizers (such as lithium, carbamazepine, valproic acid or verapamil) within two weeks of screening
* Diagnosis of substance abuse using DSM-IV criteria within previous 12 months
* Positive urine drug screen at screening for amphetamine, cocaine or opioids
* Alcohol and/or any other drug abuse at screening
* Patients who have received clozapine within 3 months prior to screening due to intolerance to other antipsychotics or patients who have received clozapine in the p…
What they're measuring
1
To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia
Trial details
NCT IDNCT00136994
SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.