IM and Oral in Acute Exacerbation of Schizophrenia (BIZET Study)
NCT00136994
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Philadelphia, Pennsylvania
- Beijing, Beijing
- Boston, Massachusetts
- Toronto, Ontario
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 | 160 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |