A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schiz… (NCT07521683) | Clinical Trial Compass
By InvitationPhase 2
A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia
China150 participantsStarted 2025-10-20
Plain-language 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 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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;
. 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;