NCT00644800

Brief Summary

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

8 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

July 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

First QC Date

March 20, 2008

Last Update Submit

February 18, 2021

Conditions

SchizophreniaManiaDelusional DisorderAcute Exacerbation of Psychosis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores

    Days 1-3 (end of intramuscular dosing)

Secondary Outcomes (8)

  • Electrocardiogram at Visits 1 and 5

    Visits 1 (Screening) and 5 (Day 7)

  • Adverse events at Visits 2, 3, 4, and 5

    Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

  • Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5

    Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)

  • Laboratory tests at Visits 1 and 5

    Visits 1 (Screening) and 5 (Day 7)

  • Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5

    Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

  • +3 more secondary outcomes

Study Arms (1)

Arm A

EXPERIMENTAL
Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment

Also known as: Geodon, Zeldox
Arm A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hospitalized patients with psychosis
  • Eligible for intramuscular treatment
  • Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

You may not qualify if:

  • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
  • Resistance to conventional antipsychotic agents
  • A history of epilepsy
  • A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Fortaleza, Ceará, 60175-270, Brazil

Location

Pfizer Investigational Site

Salvador, Estado de Bahia, 41180-000, Brazil

Location

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, 30150-270, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Pfizer Investigational Site

São Gonçalo, Rio de Janeiro, Brazil

Location

Pfizer Investigational Site

Jardim Santa Monica SN, Salvador - BA, 40340-720, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Location

Related Links

MeSH Terms

Conditions

SchizophreniaManiaSchizophrenia, Paranoid

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 27, 2008

Study Start

July 1, 2003

Study Completion

May 1, 2004

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

BR(8)