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Clinical Trials in China / NCT06799559
Active, not recruiting Phase 3

Study on the Efficacy and Safety of QLM1016 in Schizophrenia

NCT06799559 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd
Phase
Phase 3
Started
2025-10-02
Last updated
2026-10-14

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

3-6mg QLM101610-20 mg Aripiprazole oral solution film

3-6mg QLM1016: 3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks

10-20 mg Aripiprazole oral solution film: 10-20mg Aripiprazole oral solution film plus QLM1016 dummy oral solution film administered orally once daily for 6 weeks.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
No. 8888 Lvyou Road Jinan Shandong

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RTMS for Refractory Auditory Hallucinations Based on Personalized Targets Using Magnetoencephalography Recruiting
App and Body Fat Scale in the Management of Overweight Patients Recruiting
Personalized iTBS in Real-World Clinical Settings for Schizophrenia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06799559 on ClinicalTrials.gov ↗ ← All trials in China