Study on the Efficacy and Safety of QLM1016 in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-6mg QLM1016, 10-20 mg Aripiprazole oral solution film.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia
Overview
The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.
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.
Primary outcome measures
- change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score [Time frame: Time Frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06799559 · QLM1016-301