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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136994
First received: August 25, 2005
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 160
Study Start Date: March 2003
Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136994

Locations
Italy
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, Italy, 16132
Pfizer Investigational Site
Genova-sestri, Italy, 16154
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136994     History of Changes
Other Study ID Numbers: A1281045
Study First Received: August 25, 2005
Last Updated: July 28, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014