Back to resultsKahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study
Primary Purpose
Schizophrenia, Psychotic Disorders
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olanzapine
ziprasidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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 Outcome Measures
- 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
Full Information
NCT ID
NCT00145444
First Posted
September 1, 2005
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00145444
Brief Title
Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study
Official Title
A Multicenter, Double-Blind, Randomized Trial Of Ziprasidone (80 - 160 Mg) Versus Olanzapine (10 - 20 Mg) In Patients With Recent-Onset Schizophrenia, Schizoaffective And Schizophreniform Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
- 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Antwerpen
ZIP/Postal Code
B-2060
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Duffel
ZIP/Postal Code
B-2570
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kortenberg
ZIP/Postal Code
B-3070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Ermelo
ZIP/Postal Code
NL-3851 PB
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Groningen
ZIP/Postal Code
NL-9713 GZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
ZIP/Postal Code
NL-6525 GC
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19542525
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281006&StudyName=Kahn+Study
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study
We'll reach out to this number within 24 hrs