To evaluate the efficacy of Jieyu Chufan Capsules, with placebo as the control, in combination with SSRIs in patients with moderate and severe depression.
To observe the safety of Jieyu Chufan Capsules and its effects in improving the side effects of SSRIs.
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;
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.);
With refractory depression (no response to adequate treatment with 2 or more antidepressants) as determined by the investigator or previously diagnosed;
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;
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;
Parallel
Jieyu Chufan Capsules
Drug4 capsules, tid; 8 weeks
Jieyu Chufan Capsules simulant
Drug4 capsules, tid; 8 weeks
Change in HAMD-17 score from baseline at Week 8.
Response rate in HAMD-17 at Week 8 relative to baseline
Remission rate in HAMD-17 at Week 8 relative to baseline
Change in HAMA score from baseline at Week 8
Change in QIDS-SR16 score from baseline at Week 8
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