A Phase II Clinical Study to Evaluate the Efficacy and Safety of NS-136 in the Treatment of Schizophrenia

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;