This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.
Subject who voluntarily participate in and sign the informed consent form;
Male or female subjects aged ≥ 18 years and < 65 years;
Body mass index (BMI) 18.5 ~ 38.0 kg/m2 (including boundary value);
Subjects with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical history, and stable for at least 1 month;
Has comorbid abnormal involuntary movement(s) that is more prominent than TD as judged by the investigator;
Has Simpson-Angus Scale (SAS) score≥ 3 on two or more items other than items 8 and 10;
Currently in the acute phase of mental disorder or severe psychiatric symptoms, unable to cooperate with the treatment and assessment, as judged by the investigator;
Has a history of suicide attempt or Question 4 or Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as "Yes" within the past 6 months;
Parallel
LPM3770164 sustained release tablet 5 mg
DrugLPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks
LPM3770164 sustained release tablet 10 mg
DrugLPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks.
LPM3770164 sustained release tablet 20 mg
DrugLPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks.
LPM3770164 sustained release tablet simulant
DrugLPM3770164 sustained release tablet simulant once daily oral for 6 weeks.
Treatment-emergent adverse event
Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score
Clinical Global Impression - Global Improvement of TD (CGI-TD)
Patient Global Impression of Change (PGIC)
Maximum observed concentration (Cmax)
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