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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136994
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 29, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ziprasidone Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial to Evaluate the Efficacy and Tolerability of Ziprasidone IM and Oral in Patients With Psychosis and Acute Agitation.
Study Start Date : March 2003
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 < 180 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 interval
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136994

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Pfizer Investigational Site
Savigliano, Cuneo, Italy, 12038
Pfizer Investigational Site
Campi Bisenzio, Firenze, Italy, 50013
Pfizer Investigational Site
Sora, Frosinone, Italy, 3039
Pfizer Investigational Site
Parma, PR, Italy, 43100
Pfizer Investigational Site
S. Arsenio, Salerno, Italy, 84037
Pfizer Investigational Site
Bologna, Italy, 40100
Pfizer Investigational Site
Cagliari, Italy, 09100
Pfizer Investigational Site
Caserta, Italy, 81100
Pfizer Investigational Site
Chiari (bs), Italy, 25032
Pfizer Investigational Site
Cremona, Italy, 26100
Pfizer Investigational Site
Fidenza(pr), Italy, 43036
Pfizer Investigational Site
Foggia, Italy, 71100
Pfizer Investigational Site
Genova-sestri, Italy, 16154
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Lecce, Italy, 73100
Pfizer Investigational Site
Milano, Italy, 20142
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Moncalieri(to), Italy, 10024
Pfizer Investigational Site
Napoli, Italy, 80136
Pfizer Investigational Site
Noto, Italy, 96017
Pfizer Investigational Site
Orbassano (to), Italy, 10043
Pfizer Investigational Site
Padova, Italy, 35128
Pfizer Investigational Site
Palermo, Italy, 90145
Pfizer Investigational Site
Perugia, Italy, 06100
Pfizer Investigational Site
Pordenone, Italy, 33170
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Sassari, Italy, 07100
Pfizer Investigational Site
Senigallia (an), Italy, 60019
Pfizer Investigational Site
Torino, Italy, 10126
Pfizer Investigational Site
Torino, Italy, 10154
Pfizer Investigational Site
Torrette Di Ancona (an), Italy, 60020
Pfizer Investigational Site
Udine, Italy, 33100
Pfizer Investigational Site
Verona, Italy, 37063
Pfizer Investigational Site
Viareggio, Italy, 55049
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Layout table for additonal information Identifier: NCT00136994    
Other Study ID Numbers: A1281045
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents