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

NCT06749470 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2024-10-22-674
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Jieyu Chufan Capsules; TCM; Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Change in HAMD-17 score from baseline at Week 8.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

• Response rate in HAMD-17 at Week 8 relative to baseline

  From enrollment to the end of treatment at 8 weeks

• Remission rate in HAMD-17 at Week 8 relative to baseline

  From enrollment to the end of treatment at 8 weeks

• Change in HAMA score from baseline at Week 8

  From enrollment to the end of treatment at 8 weeks

• Change in QIDS-SR16 score from baseline at Week 8

  From enrollment to the end of treatment at 8 weeks

• Change in GAD-7 score from baseline at Week 8

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Test Group

EXPERIMENTAL

Jieyu Chufan Capsules Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box Administration: 4 capsules, tid, 8 weeks

Drug: Jieyu Chufan Capsules

Control Group

PLACEBO COMPARATOR

Jieyu Chufan Capsules Placebo Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box. Administration: 4 capsules, tid; 8 week

Drug: Jieyu Chufan Capsules simulant

Interventions

Jieyu Chufan Capsules DRUG

4 capsules, tid; 8 weeks

Test Group

Jieyu Chufan Capsules simulant DRUG

4 capsules, tid; 8 weeks

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• With other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumor, epilepsy, and severe rheumatism;
• 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;
• Allergic to the investigational drug or its ingredients;
• In lactation, of childbearing potential, or planning to be pregnant;
• With alcohol and drug dependence;
• Participating in another clinical study within 1 month prior to enrollment or for the time being.
• Not suitable for participation in this study due to potential risks or other factors as considered by the investigator.

Sponsors & Collaborators

• Central South University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Jin Liu, Doctor

CONTACT

+86 19832188333; 383505858@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: A randomized, double-blind, placebo-controlled, multicenter clinical study.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 27, 2024
• Study Start: December 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share