Clinical trial NCT00145444: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Psychotic Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: - 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
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Duffel
country: Belgium
facility: Pfizer Investigational Site
city: Kortenberg
country: Belgium
facility: Pfizer Investigational Site
city: Ermelo
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.