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 range
18 Years – 60 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.