Schizophrenia
Conditions
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.
Interventions
DRUG3-6mg QLM1016
3-6mg QLM1016 pluse Aripiprazole dummy oral solution film administered orally once daily for 6 weeks
DRUG10-20 mg Aripiprazole oral solution film
10-20mg Aripiprazole oral solution film plus QLM1016 dummy oral solution film administered orally once daily for 6 weeks.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score | Time Frame: 6 weeks |
Outcome results
None listed