NCT00645515

Brief Summary

The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

3 active sites

Status
terminated

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

June 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.3 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

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

    Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Secondary Outcomes (11)

  • Change from baseline in cognitive function assessment at Weeks 4 and 24

    Day 1 and Weeks 4 and 24

  • Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24

    Day 1 and Weeks 4, 10, 12, 16, and 24

  • Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24

    Day 1 and Weeks 1, 4, 12, 16, and 24

  • Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24

    Day 1 and Weeks 1, 4, 12, 16, and 24

  • Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24

    Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24

  • +6 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: Ziprasidone

Arm B

ACTIVE COMPARATOR
Drug: Risperidone

Interventions

ZiprasidoneDRUG

Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Also known as: Geodon, Zeldox
Arm A
RisperidoneDRUG

Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Arm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia
  • CGI-S score of 4 or less at baseline

You may not qualify if:

  • Concurrent antipsychotic treatment
  • Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
  • Acute exacerbation of schizophrenia within 3 months of baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Bilbao, Vizcaya, 48010, Spain

Location

Pfizer Investigational Site

Getxo, Vizcaya, 48990, Spain

Location

Pfizer Investigational Site

Madrid, 28007, Spain

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidoneRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 27, 2008

Study Start

June 1, 2003

Study Completion

December 1, 2003

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

ES(3)