Tests HS-10380 for acute schizophrenia in Chinese adults
Tests HS-10380 against placebo and aripiprazole in adults hospitalized with acute schizophrenia.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07911787, who can take part
Where in China
- Shanghai Mental Health CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07911787
- Record updated
- 3 November 2026
- Original description
This is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability.Read full original descriptionShow less
A Randomized, Double-Blind, Active- and Placebo-Controlled Phase 3 Clinical Study Evaluating the Efficacy and Safety of HS-10380 in Chinese Adult Patients With Acute Schizophrenia
This is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability.
Inclusion: Participant is aged 18-65 years, inclusive, at screening; Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening; Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2; Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening or baseline Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: Item 1 (P1; delusions)\Item 2 (P2; conceptual disorganization)\Item 3 (P3; hallucinatory behavior)\Item 6 (P6; suspiciousness/persecution) .
Exclusion: History of drug abuse within 1 year prior to screening; History of alcohol abuse within 6 months prior to screening; History or presence of clinically significant neuropsychiatric, cardiovascular, urinary, digestive, respiratory, musculoskeletal, metabolic/endocrine, hematological, immune, dermatological, and oncological systems disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results; History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome; Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria; History of severe allergic reactions; Abnormal laboratory parameters at screening or baseline; Judged by the investigator as having treatment-resistant schizophrenia; Patients with risk of violent or destructive behavior, or suicidal risk; Female patients who are pregnant, in puerperium, or lactating at screening or baseline; Abnormal vital signs at screening or baseline; Abnormal 12-lead ECG at screening or baseline.