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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

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NCT00145444

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Antwerpen, , B-2060 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Psychotic Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Duration of illness CGI severity score > 4 (moderately ill)

- maximum exposure to antipsychotic treatment of =

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Concurrent treatment with antipsychotic agents =

- 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 =

- for MAOIs and moclobemide this period must =

- for fluoxetine =

NCT00145444
Pfizer
Completed
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

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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
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Drug: olanzapine
  • Drug: ziprasidone
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
 
NCT00145444
A1281006
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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