NCT06799559

Study on the Efficacy and Safety of QLM1016 in Schizophrenia

A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	3-6mg QLM1016	3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks
DRUG	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-01-29
• Last updated: 2025-01-29