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

NCT00136994

Last updated date
Study Location
Pfizer Investigational Site
Savigliano, Cuneo, 12038, Italy
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
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.
Show details

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


- 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

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
Official Title  ICMJE An Open Trial to Evaluate the Efficacy and Tolerability of Ziprasidone IM and Oral in Patients With Psychosis and Acute Agitation.
Brief Summary To evaluate efficacy and tolerability of Ziprasidone IM and oral in agitated patients with acute exacerbation of schizophrenia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Ziprasidone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 25, 2005)
160
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136994
Other Study ID Numbers  ICMJE A1281045
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP