Study on the Efficacy and Safety of QLM1016 in Schizophrenia

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: 10-20 mg Aripiprazole oral solution film; Drug: 3-6mg QLM1016

Study type: Interventional

Funder types: Industry

Identifiers

NCT06799559

QLM1016-301

Details and patient eligibility

About

The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.

Enrollment: 402 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
• PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
• CGI-S score ≥ 4

Exclusion criteria

• Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
• known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

402 participants in 2 patient groups

QLM1016

Experimental group

Treatment:

Drug: 3-6mg QLM1016

Aripiprazole oral solution film

Active Comparator group

Treatment:

Drug: 10-20 mg Aripiprazole oral solution film