Study on the Efficacy and Safety of QLM1016 in Schizophrenia
NCT ID: NCT06799559
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
402 participants
INTERVENTIONAL
2025-05-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QLM1016
3-6mg QLM1016
3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks
Aripiprazole oral solution film
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.
Interventions
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3-6mg QLM1016
3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study
18 Years
65 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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QLM1016-301
Identifier Type: -
Identifier Source: org_study_id
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