A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study on the Treatment of Depression with Jieyu Chufan Capsules

Korábbi kezelés

• With refractory depression (no response to adequate treatment with 2 or more antidepressants) as determined by the investigator or previously diagnosed;
• Receiving non-drug therapies, such as electric convulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and systematic psychotherapy 10 or more times in the last 6 months;
• Allergic to the investigational drug or its ingredients;
• With alcohol and drug dependence;
• Participating in another clinical study within 1 month prior to enrollment or for the time being.

Más betegség

• Meeting the DSM-5 diagnostic criteria for mental disorders other than depression (e.g., patients with schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, compulsive and related disorders, etc.);
• At a significant risk of suicide (HAMD-17 Item 3 (suicide) score ≥3) as judged by the investigator, or with a history of suicide attempts in the last year;
• With other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumor, epilepsy, and severe rheumatism;

Laborértékek

• With clinically significant abnormalities in 12-lead ECG that may affect the safety of the subject, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significantly prolonged QTc (QTc >450 ms in men and >470 ms in women);
• With severe hepatic and renal insufficiency, i.e., aspartate transaminase (AST) ≥1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT) ≥1.5 × ULN, and serum creatinine (Scr) ≥1.5× ULN;

Egyéb

• In lactation, of childbearing potential, or planning to be pregnant;
• Not suitable for participation in this study due to potential risks or other factors as considered by the investigator.

• Aged 18-65 years (inclusive);
• With first-episode or relapsed depression that meets the DSM-5 diagnostic criteria;
• With a Hamilton's Depression Scale (HAMD-17) score of ≥18 at enrollment;
• Receiving no antidepressants within 2 weeks (fluoxetine within 6 weeks) prior to enrollment;
• Willing to sign the informed consent form (ICF).