NCT00145444

Brief Summary

This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the findings of an open study -where stable patients receiving olanzapine switched to ziprasidone- which showed maintenance of clinical effect with improvements in all domains of cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a well-controlled double-blind fashion will allow an evaluation of the effect on cognitive function in the short and long-term management of patients with recent-onset schizophrenia, schizoaffective and schizophreniform disorder.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2003

Typical duration for phase_3 schizophrenia

Geographic Reach
2 countries

7 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

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 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

September 1, 2005

Last Update Submit

February 18, 2021

Conditions

SchizophreniaPsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • The effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy in a 8 week period from the baseline visit to the end of week 8 visit.

Secondary Outcomes (1)

  • - to demonstrate effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy over a 24-week and one year period from baseline visit to the end of week 24 and week 52 visit

Interventions

olanzapineDRUG
ziprasidoneDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Duration of illness \< 5 years (according to DSM-IV and onset first psychotic episode); CGI severity score \> 4 (moderately ill)
  • maximum exposure to antipsychotic treatment of =\< 16 weeks.

You may not qualify if:

  • Concurrent treatment with antipsychotic agents =\< 12 hours prior to randomization
  • for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and randomization
  • Treatment with antidepressants or mood stabilizers =\< 7 days of randomization
  • for MAOIs and moclobemide this period must =\< 2 weeks
  • for fluoxetine =\< 5 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Antwerp, B-2060, Belgium

Location

Pfizer Investigational Site

Duffel, B-2570, Belgium

Location

Pfizer Investigational Site

Kortenberg, B-3070, Belgium

Location

Pfizer Investigational Site

Ermelo, NL-3851 PB, Netherlands

Location

Pfizer Investigational Site

Groningen, NL-9713 GZ, Netherlands

Location

Pfizer Investigational Site

Nijmegen, NL-6525 GC, Netherlands

Location

Pfizer Investigational Site

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • Grootens KP, van Veelen NM, Peuskens J, Sabbe BG, Thys E, Buitelaar JK, Verkes RJ, Kahn RS. Ziprasidone vs olanzapine in recent-onset schizophrenia and schizoaffective disorder: results of an 8-week double-blind randomized controlled trial. Schizophr Bull. 2011 Mar;37(2):352-61. doi: 10.1093/schbul/sbp037. Epub 2009 Jun 19.

    PMID: 19542525DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Olanzapineziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

March 1, 2003

Study Completion

November 1, 2005

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

BE(3)NL(4)