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Study on the Efficacy and Safety of QLM1016 in Schizophrenia

NCT06799559 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2025-01-29

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-07-31
Completion
2026-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799559 on ClinicalTrials.gov