A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd

About this trial

The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia

Eligibility criteria

Qualifiers

Of patients with schizophrenia in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria, who are judged that administration of low dose is more appropriate than initial recommended dose or standard titration dose of olanzapine to consider medical conditions by investigator

Patients with the duration of schizophrenia for more than 1 year at screening visit(Visit 1)

Disqualifiers

Patients diagnosed schizophrenia spectrum and other psychotic disorder(e.g. schizoaffective disorder, etc.), bipolar disorder, depressive disorder, etc., in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria at screening visit(Visit 1)

Patients with a history of hospitalization for worsening schizophrenia within 12 weeks at screening visit(Visit 1)

Trial design

Treatments tested in this trial

  • BR5402A
  • BR5402A-1
  • BR5402B
  • BR5402B-1
  • BR5402C
  • BR5402C-1
  • BR5402D
  • BR5402D-1

Treatment groups

120 Participants
are divided into 2 treatment groups