Loading clinical trials...

IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)

An Open Trial to Evaluate the Efficacy and Tolerability of Ziprasidone IM and Oral in Patients With Psychosis and Acute Agitation.

NCT00136994•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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 Â³ 3 on at least three of the following PANSS agitation items: anxiety , tension, hostility, excitement).
•CGI-S Â³ 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 past two years for refractoriness to treatment
•Treatment with any investigational agent within the previous six months
+15 more criteria

Locations (34)

Pfizer Investigational Site

Savigliano, Cuneo, Italy

Pfizer Investigational Site

Campi Bisenzio, Firenze, Italy

Pfizer Investigational Site

Sora, Frosinone, Italy

Pfizer Investigational Site

Parma, PR, Italy

Pfizer Investigational Site

S. Arsenio, Salerno, Italy

Pfizer Investigational Site

Bologna, Italy

Pfizer Investigational Site

Cagliari, Italy

Pfizer Investigational Site

Caserta, Italy

Pfizer Investigational Site

Chiari (BS), Italy

Pfizer Investigational Site

Cremona, Italy

Key Dates

Start Date

March 1, 2003

Completion Date

November 1, 2005

Last Updated

February 21, 2021

Enrollment

160

Estimated participants

Conditions

Schizophrenia

Interventions

Ziprasidone

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Brain Stimulation to the Hippocampus in Schizophrenia

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques