NCT06799559Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 402 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 2 Oct 2025
- Primary completion date
- 23 Oct 2026
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Schizophrenia
- NCT number
- NCT06799559
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 402
- From 2 Oct 2025 to the primary completion date, 23 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| No. 8888 Lvyou Road Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.