SCHIZOPHRENIA 1 (Disorder)Phase 3NCT07911787
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
A Phase 3 study testing HS-10380 and Aripiprazole in people with SCHIZOPHRENIA 1 (Disorder), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder)
- What is being tested?
- HS-10380 and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2026to 7 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) .
Who cannot join
- Judged by the investigator as having treatment-resistant schizophrenia.
- Patients with risk of violent or destructive behavior, or suicidal risk.
- 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.
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- Female patients who are pregnant, in puerperium, or lactating at screening or baseline.
- History of drug abuse within 1 year prior to screening.
- History of alcohol abuse within 6 months prior to screening.
- Abnormal vital signs at screening or baseline.
- Abnormal 12-lead ECG at screening or baseline.
- Abnormal laboratory parameters at screening or baseline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, No. 604, Lingling Road
Huafang Li, 021-34773107, lhlh_5@163.com
About this study
Official title: 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.
Read the detailed description
This trial is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1) to receive HS-10380 (1.5-3mg), HS-10380 (4.5-6mg) , placebo and aripiprazole, with the primary endpoint as the change from baseline in PANSS total score on D42.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Being tested
- HS-10380, Aripiprazole, Placebo
- Keywords
- Schizophrenia, PANSS, HS-10380
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10380Drug
Oral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose
AripiprazoleDrug
Oral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose
PlaceboDrug
Oral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose
| Study group | Role | What they receive |
|---|---|---|
| HS-10380 Low Dose | Experimental | Not described Receives: Drug: HS-10380 |
| HS-10380 High Dose | Experimental | Not described Receives: Drug: HS-10380 |
| Aripiprazole | Active comparator | Not described Receives: Drug: Aripiprazole |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Measured: Baseline and Week 6
Secondary outcomes (5)
Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% and 50% Change in PANSS Total Score) at Day 42
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 40% change in PANSS total score compared to baseline at D42
Measured: Baseline and Week 6
Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline
The Marder 5-factor model is a validated subscale classification of the Positive and Negative Syndrome Scale (PANSS), which was proposed by psychiatrist Stephen R. Marder to refine the dimensional assessment of symptom severity in schizophrenia. It divides the 30 items of the PANSS into five distinct symptom domains, namely: Positive symptoms；Negative symptoms；Disorganization symptoms；Excitement/hostility symptoms；Anxiety/depression symptoms.
Measured: Baseline and Week 6
Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline
The Calgary Depression Scale for Schizophrenia (CDSS) is a disease-specific, validated rating scale designed exclusively to assess depressive symptoms in patients with schizophrenia. Unlike general depression scales, it avoids overlap with schizophrenia core symptoms (e.g., anhedonia, avolition) that may mimic depressive manifestations, thus ensuring the accuracy of depression symptom evaluation in this population. The scale consists of 9 items, each rated on a 4-point Likert scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The items cover key depressive domains including depressed mood, hopelessness, suicidal ideation, guilt feelings, insomnia, reduced appetite, early morning awakening, psychomotor retardation, and inability to feel pleasure.
Measured: Baseline and Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Measured: Baseline and Week 6
Clinical Global Impression-Improvement (CGI-I) Score at Day 42
The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale used to assess the patient's improvement relative to baseline status. The scale ranges from 1 to 7, with lower scores indicating greater improvement:1 = Very much improved;2 = Much improved;3 = Minimally improved;4 = No change;5 = Minimally worse;6 = Much worse;7 = Very much worse.
Measured: Week 1 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion24 Jan 2029 (estimated)
- Study completion7 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911787
- Sponsor's protocol ID
- HS-10380-301
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07911787
- Acronym / sponsor ID
- HS-10380-301
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Keywords
- Schizophrenia, PANSS, HS-10380
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 24 Jan 2029 (estimated)
- Study completion
- 7 Feb 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study, aims to further evaluate the efficacy and safety of HS-10380 in participants with acute schizophrenia, who were randomized (2:2:2:1) to receive HS-10380 (1.5-3mg), HS-10380 (4.5-6mg) , placebo and aripiprazole, with the primary endpoint as the change from baseline in PANSS total score on D42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-10380 Low Dose | Experimental | Drug: HS-10380 |
| HS-10380 High Dose | Experimental | Drug: HS-10380 |
| Aripiprazole | Active comparator | Drug: Aripiprazole |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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) .
Key exclusion criteria (12 listed)
- Judged by the investigator as having treatment-resistant schizophrenia.
- Patients with risk of violent or destructive behavior, or suicidal risk.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10380Oral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose | Drug | HS-10380 High Dose, HS-10380 Low Dose |
| AripiprazoleOral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose | Drug | Aripiprazole |
| PlaceboOral；QD；W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose | Drug | placebo |
Primary outcome
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42)
Time frame: Baseline and Week 6
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
5 secondary outcomes
Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% and 50% Change in PANSS Total Score) at Day 42
Time frame: Baseline and Week 6
Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline
Time frame: Baseline and Week 6
Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline
Time frame: Baseline and Week 6
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42
Time frame: Baseline and Week 6
Clinical Global Impression-Improvement (CGI-I) Score at Day 42
Time frame: Week 1 and Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-10380 and Aripiprazole in people with SCHIZOPHRENIA 1 (Disorder), run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li (021-34773107, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42) (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.