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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-65 who are in hospital with an acute episode of schizophrenia, to test the drug HS-10380.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Acute schizophrenia diagnosed by DSM-5 criteria and confirmed by the MINI version 7.0.2 interview. PANSS total score between 80 and 120, and a score of 4 or more on at least 2 of 4 listed symptom items (delusions, disorganized thinking, hallucinatory behavior, suspiciousness).
- Earlier treatment
- People judged by the investigator to have treatment-resistant schizophrenia cannot join.
Main reasons for not taking part
- Treatment-resistant schizophrenia
- Risk of violent or destructive behavior, or suicide risk
- History of epilepsy (except febrile convulsions) or neuroleptic malignant syndrome
- Pregnant, in puerperium or breastfeeding women
- Drug abuse within 1 year or alcohol abuse within 6 months before screening
Read by machine on 12 November 2026.
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, ChinaContact: Huafang LiNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.