NCT00136994

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2003

Typical duration for phase_3 schizophrenia

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

First QC Date

August 25, 2005

Last Update Submit

February 18, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

Interventions

ZiprasidoneDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Pfizer Investigational Site

Savigliano, Cuneo, 12038, Italy

Location

Pfizer Investigational Site

Campi Bisenzio, Firenze, 50013, Italy

Location

Pfizer Investigational Site

Sora, Frosinone, 3039, Italy

Location

Pfizer Investigational Site

Parma, PR, 43100, Italy

Location

Pfizer Investigational Site

S. Arsenio, Salerno, 84037, Italy

Location

Pfizer Investigational Site

Bologna, 40100, Italy

Location

Pfizer Investigational Site

Cagliari, 09100, Italy

Location

Pfizer Investigational Site

Caserta, 81100, Italy

Location

Pfizer Investigational Site

Chiari (BS), 25032, Italy

Location

Pfizer Investigational Site

Cremona, 26100, Italy

Location

Pfizer Investigational Site

Fidenza(pr), 43036, Italy

Location

Pfizer Investigational Site

Foggia, 71100, Italy

Location

Pfizer Investigational Site

Genova, 16132, Italy

Location

Pfizer Investigational Site

Genova-sestri, 16154, Italy

Location

Pfizer Investigational Site

Lecce, 73100, Italy

Location

Pfizer Investigational Site

Milan, 20142, Italy

Location

Pfizer Investigational Site

Modena, 41100, Italy

Location

Pfizer Investigational Site

Moncalieri(to), 10024, Italy

Location

Pfizer Investigational Site

Napoli, 80136, Italy

Location

Pfizer Investigational Site

Noto, 96017, Italy

Location

Pfizer Investigational Site

Orbassano (TO), 10043, Italy

Location

Pfizer Investigational Site

Padua, 35128, Italy

Location

Pfizer Investigational Site

Palermo, 90145, Italy

Location

Pfizer Investigational Site

Perugia, 06100, Italy

Location

Pfizer Investigational Site

Pordenone, 33170, Italy

Location

Pfizer Investigational Site

Roma, 00149, Italy

Location

Pfizer Investigational Site

Sassari, 07100, Italy

Location

Pfizer Investigational Site

Senigallia (AN), 60019, Italy

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Pfizer Investigational Site

Torino, 10154, Italy

Location

Pfizer Investigational Site

Torrette DI Ancona (AN), 60020, Italy

Location

Pfizer Investigational Site

Udine, 33100, Italy

Location

Pfizer Investigational Site

Verona, 37063, Italy

Location

Pfizer Investigational Site

Viareggio, 55049, Italy

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

March 1, 2003

Study Completion

November 1, 2005

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

IT(34)