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

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
Savigliano, Cuneo, 12038 Italy
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- Previous treatment with ziprasidone

- Organic mental disease, including mental retardation

- History of psychosurgery

- General:

- Patients with a history of clinically significant and/or currently relevant
hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine
(except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding
chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease),
dermatological, oncological, or neurological disease, excluding tardive dyskinesia but
including all forms of epilepsy (febrile convulsions in childhood acceptable). The
only patients with known prior malignant disease who are eligible are those with cured
prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will
not be considered a significant medical illness and would not exclude a subject from
the study - Patients with a history of significant cardiovascular disease or
significant concurrent cardiovascular disease, including a history of uncontrolled
hypertension (supine diastolic pressure >95 mm Hg and/or supine systolic pressure >
170 mm Hg with or without treatment)

- Clinically significant ECG abnormality

- Patient with QTc ³ 450 msec - Concomitant treatment with medications that prolong QT

- Patients with serum K+ or Mg++ outside the normal range

- Confirmed clinically significant laboratory values.

- Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase
levels higher than three times the normal limits)

- Patients who intend to donate blood or blood products during the 4 weeks prior to the
study, during the study or in the 30 days after the study ends

- Patients unable or unlikely to follow the study protocol

- Pregnant or lactating women

- Patients with a history of neuroleptic malignant syndrome developing from the
administration of antipsychotic compounds

- Known hypersensitivity to ziprasidone or lactose

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


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