NCT00137020

Brief Summary

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline

Trial Health

93
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
9 countries

27 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

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

First QC Date

August 26, 2005

Last Update Submit

February 18, 2021

Conditions

SchizophreniaPsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcomes (13)

  • Change From Baseline In Clinical Global Impression Severity (CGI-S)

  • Clinical Global Impression Improvement (CGI-I)

  • Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total

  • Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)

  • Change from baseline in scores on the MADRS Without Items 4, 5

  • +8 more secondary outcomes

Interventions

ziprasidoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
  • Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert

You may not qualify if:

  • Resistance to conventional antipsychotic drugs
  • With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Pfizer Investigational Site

Alexandria, Egypt

Location

Pfizer Investigational Site

Asyut, Egypt

Location

Pfizer Investigational Site

Cairo, Egypt

Location

Pfizer Investigational Site

Tanta, Egypt

Location

Pfizer Investigational Site

Larissa, Mezourlo, 41110, Greece

Location

Pfizer Investigational Site

Athens, 11528, Greece

Location

Pfizer Investigational Site

Athens, 12462, Greece

Location

Pfizer Investigational Site

Athens, 15126, Greece

Location

Pfizer Investigational Site

Jordan, Jordan

Location

Pfizer Investigational Site

Kuwait City, 13041, Kuwait

Location

Pfizer Investigational Site

Beirut, Lebanon

Location

Pfizer Investigational Site

Khobar, 31451, Saudi Arabia

Location

Pfizer Investigational Site

Garankuwa, Gauteng, 0208, South Africa

Location

Pfizer Investigational Site

Krugersdorp, Gauteng, 1739, South Africa

Location

Pfizer Investigational Site

Noordheuwel, Krugersdorp, Gauteng, 1739, South Africa

Location

Pfizer Investigational Site

Bellair, Durban, KwaZulu-Natal, 4094, South Africa

Location

Pfizer Investigational Site

Pinetown, Durban, KwaZulu-Natal, 3600, South Africa

Location

Pfizer Investigational Site

Observatory, Cape Town, Western Cape, 7925, South Africa

Location

Pfizer Investigational Site

Ankara, Turkey (Türkiye)

Location

Pfizer Investigational Site

Bursa, Turkey (Türkiye)

Location

Pfizer Investigational Site

Erzurum, Turkey (Türkiye)

Location

Pfizer Investigational Site

Istanbul, Turkey (Türkiye)

Location

Pfizer Investigational Site

Izmir, 35340, Turkey (Türkiye)

Location

Pfizer Investigational Site

Izmir, Turkey (Türkiye)

Location

Pfizer Investigational Site

Manisa, Turkey (Türkiye)

Location

Pfizer Investigational Site

Şişli, Turkey (Türkiye)

Location

Pfizer Investigational Site

Dubai, United Arab Emirates

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

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

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

November 1, 2004

Study Completion

April 1, 2006

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

EG(4)LE(1)ZA(6)TU(8)AE(1)KU(1)JO(1)SA(1)GR(4)