A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia

ConditionSchizophrenia

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorLuye Pharma Group Ltd.

About this trial

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects and their guardians sign informed consent voluntarily.

Male or female subject aged 18 to 65 years (inclusive).

Subject meets DSM-5 criteria for schizophrenia and confirmed using the Mandarin for China Translation Version 7.0.2).

According to the investigator's assessment, subject has an acute exacerbation or relapse of schizophrenia requiring hospitalization (no longer than 2 months). Continuing hospitalization does not exceed 2 weeks for patients with acute psychotic exacerbation or relapse that require the hospitalization prior to screening.

Disqualifiers

- Subject who has a history or presence of symptoms consistent with a major psychiatric disorder other than schizophrenia as defined by DSM-5;

According to the investigator's assessment, subject has a treatment-resistant schizophrenia;

Subject who has a history or presence of symptoms consistent with neuroleptic malignant syndrome (NMS);

Subject has received electroconvulsive therapy treatment within 3 months prior to screening or is expected to require ECT during the study;

Trial design

Design model

Parallel

Treatments tested in this trial

LY03020
Drug
administered orally
Placebo
Drug
administered orally

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: LY03020Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes