Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Subject who voluntarily participate in and sign the informed consent form; 2. Male or female subjects aged ≥ 18 years and \< 65 years; 3. Body mass index (BMI) 18.5 \~ 38.0 kg/m2 (including boundary value); 4. 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; 5. Subjects who have been diagnosed with medication-induced TD, and whose symptoms have lasted for at least 3 months according to the DSM-5; and TD is assessed as moderate or severe (AIMS Item 8 score ≥3); 6. Medications for schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders and extrapyramidal reactions should be kept dose stable for at least 1 month (benzodiazepines should stable at least 14 days, Long-acting injection should stable for at least 3 months); 7. Females of childbearing potential have a negative pregnancy test. Male and