About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LPM3770164 sustained release tablet 5 mg
- LPM3770164 sustained release tablet 10 mg
- LPM3770164 sustained release tablet 20 mg
- LPM3770164 sustained release tablet simulant