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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00136994
Collaborator
(none)
160
Enrollment
34
Locations
32.1
Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2003
Actual Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Savigliano Cuneo Italy 12038
2 Pfizer Investigational Site Campi Bisenzio Firenze Italy 50013
3 Pfizer Investigational Site Sora Frosinone Italy 3039
4 Pfizer Investigational Site Parma PR Italy 43100
5 Pfizer Investigational Site S. Arsenio Salerno Italy 84037
6 Pfizer Investigational Site Bologna Italy 40100
7 Pfizer Investigational Site Cagliari Italy 09100
8 Pfizer Investigational Site Caserta Italy 81100
9 Pfizer Investigational Site Chiari (BS) Italy 25032
10 Pfizer Investigational Site Cremona Italy 26100
11 Pfizer Investigational Site Fidenza(pr) Italy 43036
12 Pfizer Investigational Site Foggia Italy 71100
13 Pfizer Investigational Site Genova-sestri Italy 16154
14 Pfizer Investigational Site Genova Italy 16132
15 Pfizer Investigational Site Lecce Italy 73100
16 Pfizer Investigational Site Milano Italy 20142
17 Pfizer Investigational Site Modena Italy 41100
18 Pfizer Investigational Site Moncalieri(to) Italy 10024
19 Pfizer Investigational Site Napoli Italy 80136
20 Pfizer Investigational Site Noto Italy 96017
21 Pfizer Investigational Site Orbassano (to) Italy 10043
22 Pfizer Investigational Site Padova Italy 35128
23 Pfizer Investigational Site Palermo Italy 90145
24 Pfizer Investigational Site Perugia Italy 06100
25 Pfizer Investigational Site Pordenone Italy 33170
26 Pfizer Investigational Site Roma Italy 00149
27 Pfizer Investigational Site Sassari Italy 07100
28 Pfizer Investigational Site Senigallia (AN) Italy 60019
29 Pfizer Investigational Site Torino Italy 10126
30 Pfizer Investigational Site Torino Italy 10154
31 Pfizer Investigational Site Torrette DI Ancona (AN) Italy 60020
32 Pfizer Investigational Site Udine Italy 33100
33 Pfizer Investigational Site Verona Italy 37063
34 Pfizer Investigational Site Viareggio Italy 55049

Sponsors and Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00136994
Other Study ID Numbers:
  • A1281045
First Posted:
Aug 29, 2005
Last Update Posted:
Feb 21, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:
Schizophrenia
Ziprasidone

Study Results

No Results Posted as of Feb 21, 2021