Study on the Efficacy and Safety of QLM1016 in Schizophrenia

Phase 3

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: 3-6mg QLM1016; Drug: 10-20 mg Aripiprazole oral solution film

• Registration Number: NCT06799559
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-05
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLM1016	3-6mg QLM1016	-
Aripiprazole oral solution film	10-20 mg Aripiprazole oral solution film	-

Primary Outcome Measures

Name	Time	Method
change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score	Time Frame: 6 weeks