This is a non-Inferiority trial to evaluate efficacy and safety of hydrochloride carliprazine capsules and aripiprazole tablets in treating acute schizophrenia in Chinese adults. 376 patients will be randomizdely assigned in a 1:1 ratio to treatment group and control group. All enrolled subjects will be orally administered with hydrochloride carliprazine capsules or aripiprazole tablets for 6 consecutive weeks.
Subjects between 18 and 65 years, male and female;
Subjects diagnosed with schizophrenia (according to the DSM-IV criteria);
Subjects with a PANSS Total score between 70-120, with a score of at least 4 on two or more of the items of delusions, hallucinatory behavior, conceptual disorganization, or suspiciousness;
Subjects with a CGI-S score ≥4;
Other mental illnesses that meet DSM-5 criteria, excluding schizophrenia, including but not limited to: major depressive disorder, bipolar disorder and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, bulimia nervosa/anorexia nervosa, neurodevelopmental disorders, schizoaffective disorder, and any other mental illness that may affect subject compliance;
Subjects who have been hospitalized for > 21 days for the current acute episode.
Subjects with a history of substance abuse or dependence (excluding nicotine or caffeine) in the past 3 months, or those who test positive in the urine drug screening during the screening period (Subjects who test positive in the urine drug screening may be allowed to participate in the study at the researcher's discretion, or may participate if they cease using such substances prior to the trial). Use of narcotic analgesics for a maximum of 3 days is permitted during the trial for clinical medical needs;
Subjects who have history of substance abuse or dependence within 3 months, but excluding caffeine and nicotine. Invesgtigators have the right to decide whether subjects who are positive in urine drug screening can be enrolled in the study, or those who have stopped drug use before screening can be enrolled. During the study, the use of up to 3 days of anesthetic analgesics is allowed for medical purposes.
Parallel
Hydrochloride Carliprazine capsules
DrugOral administration, once daily, with a total treatment duration of 6 weeks after successful screening.
Aripiprazole tablets
DrugOral administration, once daily, with a total treatment duration of 6 weeks after successful screening.
PANSS
Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.
PANSS
Change in the Positive and Negative Syndrome Scale (PANSS) score from baseline.
CGI-S
Change in Clinical Global Impression Severity Scale (CGI-S) score from baseline.
CGI-I
Change in Clinical Global Impression Improvement Scale (CGI-I) score from baseline.
PSP
Change in Personal and Social Performance Scale (PSP) score from baseline.
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