Trial · NCT07911787
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
NCT07911787, Phase 3, Not yet recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults. Trials, record NCT07911787. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
- NCT number
- NCT07911787
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 476 participants, estimated
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Conditions
- SCHIZOPHRENIA 1 (Disorder)
- Interventions
- HS-10380, Aripiprazole, Placebo
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (Day 42) | 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. |
| Secondary | Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% and 50% Change in PANSS Total Score) at Day 42 | 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 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 |
| Secondary | Change in Marder 5-factor score of the PANSS scale at Day 42 compared with baseline | Baseline and Week 6 | 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. |
| Secondary | Change in Calgary Depression Scale for Schizophrenia (CDSS) score at Day 42 compared with baseline | Baseline and Week 6 | 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. |
| Secondary | Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 42 | Baseline and Week 6 | 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. |
| Secondary | Clinical Global Impression-Improvement (CGI-I) Score at Day 42 | Week 1 and Week 6 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07911787
GET https://conductscience.org/api/trials/v1/NCT07911787/registered