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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

BR5402A
Drug
Subjects take the investigational products once a day
BR5402A-1
Drug
Subjects take the investigational products once a day
BR5402B
Drug
Subjects take the investigational products once a day
BR5402B-1
Drug
Subjects take the investigational products once a day
BR5402C
Drug
Subjects take the investigational products once a day
BR5402C-1
Drug
Subjects take the investigational products once a day
BR5402D
Drug
Subjects take the investigational products once a day
BR5402D-1
Drug
Subjects take the investigational products once a day

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Gradual titration groupExperimental treatment 6 interventions

Group B: Conventional titration groupActive comparator 5 interventions

Trial outcomes

Primary outcomes

The mean change of PANSS(Positive and Negative Syndrome Scale) total score

Time frame

1, 2, 3, 5, 9 weeks from baseline(Visit 2)

Incidence of treatment-emergent adverse events

Time frame

From the administration of investigational products prescribed at baseline(Visit 2) to 11 weeks(Visit 8)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boryung Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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