NCT06749470Not yet recruitingPhase 4
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study on the Treatment of Depression with Jieyu Chufan Capsules
Source: ClinicalTrials.gov · Last updated 27 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 22 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Central South University
- Diseases
- Depression
- NCT number
- NCT06749470
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 480
- From 22 Dec 2024 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Lab values
- 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;
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.