Study on the Efficacy and Safety of QLM1016 in Schizophrenia

NCT06799559 | Not Yet Recruiting Phase 3

• 1 other identifier: QLM1016-301
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Time Frame: 6 weeks

Study Arms (2)

QLM1016

EXPERIMENTAL

Drug: 3-6mg QLM1016

Aripiprazole oral solution film

ACTIVE COMPARATOR

Drug: 10-20 mg Aripiprazole oral solution film

Interventions

3-6mg QLM1016 DRUG

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

QLM1016

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.

Aripiprazole oral solution film

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01