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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Viatris

Status and phase

Completed
Phase 3

Conditions

Psychotic Disorders
Schizophrenia

Treatments

Drug: olanzapine
Drug: ziprasidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00145444
A1281006

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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