Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06799559

Study on the Efficacy and Safety of QLM1016 in Schizophrenia

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-6mg QLM1016

Drug

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

10-20 mg Aripiprazole oral solution film

Drug

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

Primary outcomes

  1. change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score

    Time frame: Time Frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.