Schizophrenia(Acute)Phase 2NCT07521683
A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia
A Phase 2 study testing NS-136 in people with Schizophrenia(Acute), run by NeuShen Therapeutics at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to preliminarily evaluate the efficacy and safety of NS-136 in patients with schizophrenia. The study consists of a screening period, baseline period, treatment period, and follow-up period, with the screening period lasting up to 21… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia(Acute)
- What is being tested?
- NS-136
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to Dec 2026
- Phase
- Phase 2
- 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
- Male or female aged 18-65 years (inclusive) with body mass index (BMI) of 18-34 kg/m2 (inclusive);
- No participation in other clinical studies within 60 days prior to signing the informed consent form (ICF);
- Patients diagnosed with schizophrenia according to DSM-5 criteria;
- During the screening and baseline periods, subjects should have a PANSS total score of 80 or above, CGI-S score of 4 or above, moderate-to-severe illness severity, and at least 2 positive symptoms;
- Trial participants are willing to discontinue all prohibited antipsychotic medications in order to meet the wash-out period required by the study protocol;
- Trial participants are in a state of relapse or acute exacerbation of psychotic symptoms prior to signing the ICF;
- Women of childbearing potential must have a negative serum pregnancy test during the screening period. All subjects should agree to use effective contraception (see Appendix 1 for details) from the time of signing the ICF until at least 3 months after the last dose of the study drug, with no plans for sperm or egg donation;
- Subjects should fully understand the study objectives, nature, procedures, and potential adverse reactions, voluntarily participate as subjects, and sign the ICF before any study procedures are initiated.
Who cannot join
- DSM-5 Diagnosis: Subjects with the following psychiatric diagnoses should be excluded, including but not limited to intellectual disability, schizoaffective disorder, schizotypal disorder, depressive psychosis, major depressive disorder, bipolar disorder, post-traumatic stress disorder, generalized anxiety disorder, obsessive-compulsive disorder, eating disorders (bulimia nervosa, anorexia nervosa) or other anxiety disorders (except anxiety symptoms secondary to schizophrenia); dementia, dementia-like symptoms, amnesia or other cognitive disorders; borderline personality disorder, paranoid personality disorder, histrionic personality disorder, schizoid personality disorder, apathetic personality disorder or antisocial personality disorder;
- Subjects with treatment-resistant schizophrenia who have shown no response or improvement after receiving adequate doses (clinically tolerable effective doses) of two different classes of antipsychotic drugs for a minimum treatment duration of 6 weeks; or subjects who are unresponsive to clozapine treatment or responsive only to clozapine treatment;
- Subjects with unstable extrapyramidal symptoms requiring dose adjustments and/or new medication treatments within 6 months prior to signing the ICF;
- Subjects with current or past history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine (including newly diagnosed diabetes or known diabetes with HbA1c >7.5%), hematologic, immunologic, psychiatric (except schizophrenia), or neurological disorders, dysphagia, or hypersensitivity to the study drug or any of its components;
- Subjects with current or past history of major cardiovascular diseases, including any of the following: ischemic heart disease, myocardial infarction, valvular heart disease, cardiac surgical revascularization (coronary artery bypass grafting, stent placement or percutaneous transluminal coronary angioplasty), hypertension, receiving antihypertensive medications, orthostatic hypotension, angina pectoris, unstable angina, cerebrovascular accident or stroke or transient ischemic attack, pacemaker, atrial fibrillation, flutter or nonsustained or sustained ventricular tachycardia, pulmonary hypertension, sick sinus syndrome, second- or third-degree atrioventricular block, congestive heart failure, personal or family history of sudden death or long QT syndrome, unexplained syncope or syncope within the past 3 years;
- Subjects presenting with first-episode schizophrenia symptoms as judged by the investigator;
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- Subjects who, in the investigator's judgment, have exhibited acute depressive symptoms within the last 30 days requiring antidepressant treatment;
- Subjects with a history of epilepsy or seizures, excluding single seizure episodes (e.g., childhood febrile seizures) or seizures associated with trauma or alcohol withdrawal;
- Subjects with central nervous system infections, demyelinating diseases, progressive neurological disorders, intellectual disability, or any central nervous system condition deemed progressive;
- Subjects who have received systemic electroconvulsive therapy within 60 days prior to screening;
- Subjects who answer "Yes" to item 4 of the C-SSRS suicidal ideation section (active suicidal ideation without specific plan) with the most recent episode meeting this C-SSRS item 4 criterion occurring within the past 6 months, as well as those who answer "Yes" to item 5 of the C-SSRS suicidal ideation section (active suicidal ideation with specific plan and intent);
- Subjects with positive results in any of the following screening tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV), or serological testing for syphilis antibody;
- Subjects with any of the following abnormal clinical laboratory test results during the screening period (one retest is permitted at the investigator's discretion):
- AST or ALT ≥3×ULN
- Total bilirubin ≥2×ULN
- Subjects with alcohol abuse or weekly alcohol consumption exceeding 14 units (1 unit equals 17.5 mL or 14 g pure alcohol; alcohol content of different beverages is labeled by volume percentage; 1 alcohol unit approximately equals 35 mL of 50° liquor or 350 mL of 5° beer) within 4 weeks prior to screening;
- Subjects with a history of drug abuse within 1 year prior to the first dose, or positive results in the multi-drug test panel (urine) during screening (except for benzodiazepines);
- Subjects who have used moderate or strong CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose, or are expected to require moderate or strong CYP3A4 inducers or inhibitors during study participation;
- Subjects deemed by the investigator to have other factors unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia
This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to preliminarily evaluate the efficacy and safety of NS-136 in patients with schizophrenia. The study consists of a screening period, baseline period, treatment period, and follow-up period, with the screening period lasting up to 21 days.
Eligible subjects will be randomized in a 1:1:1 ratio to the 80 mg (QD) group, 120 mg (QD) group, or placebo group. The study drug treatment will last for 5 weeks, followed by a 2-week safety follow-up after completion of the study.
- Conditions
- Schizophrenia(Acute)
- Being tested
- NS-136
- Keywords
- NS-136, NeuShen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS-136Drug
NS136 80mg and 120mg
| Study group | Role | What they receive |
|---|---|---|
| 80 mg NS-136 | Experimental | Not described Receives: Drug: NS-136 |
| 120 mg NS-136 | Experimental | Not described Receives: Drug: NS-136 |
| Placebo | Placebo comparator | Not described Receives: Drug: NS-136 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive And Negative Syndrome Scale(PANSS )score
PANSS consists 3 sub-scales with 30 questions, The scoring range for each question is from 1 (no symptoms) to 7 (extremely severe symptoms).
Measured: Week 5
Secondary outcomes (7)
PANSS positive symptom score;
PANSS positive symptom includes 7 questions, The scoring range for each question is from 1 (no symptoms) to 7 (extremely severe symptoms)
Measured: Week 5
PANSS negative symptom
PANSS negative symptom includes 7 questions, The scoring range for each question is from 1 (no symptoms) to 7 (extremely severe symptoms)
Measured: Week 5
Clinical Global Impression-Severity (CGI-S)
Considering your total clinical experience with this patient population, how ill is the patient at this time, scoring from 0 (not assessed) to 7 (among the most extremely ill patients).
Measured: week 5
Clinical Global Impression-Improvement(CGI-I)
Compared to his/her condition at baseline, how much has he/she changed, scoring from 0(not assessed) to 7 (very much worse)
Measured: week 5
Extrapyramidal Symptom (EPS) rating scales
Extrapyramidal Symptom (EPS) rating scales in this study includes 3 scales: Simpson-Angus Scale (SAS) consists of 10 items, scoring from 0(normal) to 4 (Sever); Abnormal Involuntary Movement Scale (AIMS) examination consists of 12 items that rate involuntary movements in various body regions. Each item is scored on a 5-point severity scale from 0 to 4, where 0 = none, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe； Barnes Akathisia Rating Scale (BARS) Patient should be observed while they are seated, and then standing while engaged in neutral conversation (for a minimum of two minutes in each position). Objective phenomena scoring from 0 (normal) to 3 (serve), Subjective phenomena scoring from 0 (Absence of inner restlessness) to 3(sever), Global clinical assessment of akathisia phenomena scoring from 0(absent) to 5 (Severe akathisia).
Measured: week 5
Columbia-Suicide Severity Rating Scale(C-SSRS)
Assess suicidal ideation and behavior at different time points. The result shows as "yes" or "No"
Measured: week 5
Adverse Events(AE)
Adverse events and laboratory safety evaluations during the study
Measured: week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia(Acute)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuShen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521683
- Sponsor's protocol ID
- NS136SZ201
- Status last verified
- Oct 2025
- First submitted
- 11 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT07521683
- Acronym / sponsor ID
- NS136SZ201
- Conditions
- Schizophrenia(Acute)
- Keywords
- NS-136, NeuShen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NeuShen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Apr 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 randomized, double-blind, placebo-controlled, parallel-group Phase II study to preliminarily evaluate the efficacy and safety of NS-136 in patients with schizophrenia. The study consists of a screening period, baseline period, treatment period, and follow-up period, with the screening period lasting up to 21 days.
Eligible subjects will be randomized in a 1:1:1 ratio to the 80 mg (QD) group, 120 mg (QD) group, or placebo group. The study drug treatment will last for 5 weeks, followed by a 2-week safety follow-up after completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 80 mg NS-136 | Experimental | Drug: NS-136 |
| 120 mg NS-136 | Experimental | Drug: NS-136 |
| Placebo | Placebo comparator | Drug: NS-136 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18-65 years (inclusive) with body mass index (BMI) of 18-34 kg/m2 (inclusive);
- No participation in other clinical studies within 60 days prior to signing the informed consent form (ICF);
- Patients diagnosed with schizophrenia according to DSM-5 criteria;
- During the screening and baseline periods, subjects should have a PANSS total score of 80 or above, CGI-S score of 4 or above, moderate-to-severe illness severity, and at least 2 positive symptoms;
- Trial participants are willing to discontinue all prohibited antipsychotic medications in order to meet the wash-out period required by the study protocol;
Key exclusion criteria (19 listed)
- DSM-5 Diagnosis: Subjects with the following psychiatric diagnoses should be excluded, including but not limited to intellectual disability, schizoaffective disorder, schizotypal disorder, depressive psychosis, major depressive disorder, bipolar disorder, post-traumatic stress disorder, generalized anxiety disorder, obsessive-compulsive disorder, eating disorders (bulimia nervosa, anorexia nervosa) or other anxiety disorders (except anxiety symptoms secondary to schizophrenia); dementia, dementia-like symptoms, amnesia or other cognitive disorders; borderline personality disorder, paranoid personality disorder, histrionic personality disorder, schizoid personality disorder, apathetic personality disorder or antisocial personality disorder;
- Subjects with treatment-resistant schizophrenia who have shown no response or improvement after receiving adequate doses (clinically tolerable effective doses) of two different classes of antipsychotic drugs for a minimum treatment duration of 6 weeks; or subjects who are unresponsive to clozapine treatment or responsive only to clozapine treatment;
- Subjects with unstable extrapyramidal symptoms requiring dose adjustments and/or new medication treatments within 6 months prior to signing the ICF;
- Subjects with current or past history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine (including newly diagnosed diabetes or known diabetes with HbA1c >7.5%), hematologic, immunologic, psychiatric (except schizophrenia), or neurological disorders, dysphagia, or hypersensitivity to the study drug or any of its components;
- Subjects with current or past history of major cardiovascular diseases, including any of the following: ischemic heart disease, myocardial infarction, valvular heart disease, cardiac surgical revascularization (coronary artery bypass grafting, stent placement or percutaneous transluminal coronary angioplasty), hypertension, receiving antihypertensive medications, orthostatic hypotension, angina pectoris, unstable angina, cerebrovascular accident or stroke or transient ischemic attack, pacemaker, atrial fibrillation, flutter or nonsustained or sustained ventricular tachycardia, pulmonary hypertension, sick sinus syndrome, second- or third-degree atrioventricular block, congestive heart failure, personal or family history of sudden death or long QT syndrome, unexplained syncope or syncope within the past 3 years;
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 |
|---|---|---|
| NS-136NS136 80mg and 120mg | Drug | 120 mg NS-136, 80 mg NS-136, Placebo |
Primary outcome
Positive And Negative Syndrome Scale(PANSS )score
Time frame: Week 5
PANSS consists 3 sub-scales with 30 questions, The scoring range for each question is from 1 (no symptoms) to 7 (extremely severe symptoms).
7 secondary outcomes
PANSS positive symptom score;
Time frame: Week 5
PANSS negative symptom
Time frame: Week 5
Clinical Global Impression-Severity (CGI-S)
Time frame: week 5
Clinical Global Impression-Improvement(CGI-I)
Time frame: week 5
Extrapyramidal Symptom (EPS) rating scales
Time frame: week 5
Columbia-Suicide Severity Rating Scale(C-SSRS)
Time frame: week 5
Adverse Events(AE)
Time frame: week 7
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS-136 in people with Schizophrenia(Acute), run by NeuShen Therapeutics 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 8 inclusion and 19 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: enrolling by invitation, as of the sponsor's last update on 13 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive And Negative Syndrome Scale(PANSS )score (time frame: Week 5). 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 13 Apr 2026; AzTrials last refreshed its copy on 5 Nov 2026.