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Study on the Efficacy and Mechanism of Wuling Capsules Combined with Mindfulness-based Stress Reduction and escitalopram for Reshaping the frontal-cingulate - limbic Bundle in the Treatment of Major Depressive Disorder in Adolescents

Study on the Efficacy and Mechanism of Wuling Capsules Combined with Mindfulness-based Stress Reduction and escitalopram for Reshaping the frontal-cingulate - limbic Bundle in the Treatment of Major Depressive Disorder in Adolescents

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120089
Enrollment
Unknown
Registered
2026-03-09
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive disorder

Interventions

Triple therapy group:Mindfulness-based Stress reduction training (twice a week, guided by a certified instructor) + Wuling Capsules (1.0g tid) + escitalopram (10-20mg qd)
Single-drug group:escitalopram (10-20mg qd)
Healthy control group:none

Sponsors

Guangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patient inclusion criteria: 1. Age: 14 to 18 years old, gender not limited, Han ethnicity, right-handed. 2. Meet the diagnostic criteria for MDD in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) of the United States; 3. Hamilton Rating Scale for Depression 17(HAMD-17) >=17 points; The total score of the Young Manic Rating Scale (YMRS) is less than 6 points; 4. Primary school education or above; 5. Those who have not received antidepressant drug treatment for the first time or have stopped taking the drug for more than 4 weeks, and have not received any form of psychotherapy or physical therapy; 6. No other mental disorders are combined. 7. There is no obvious risk of suicide or self-harm. Inclusion criteria for healthy controls: 1. Recruit subjects from society whose age, gender and educational level are matched with the above-mentioned subjects; 2. The total score of HAMD-17 is less than 7 points, and YMRS is less than 6 points. 3. No family history of mental illness.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the patient group and the healthy control group: 1. There have been major life events within one year (such as major family changes, broken interpersonal relationships, major academic setbacks, personal health and safety incidents, etc.); 2. Has a significant history of childhood trauma (such as having suffered emotional, physical, or sexual abuse, etc.); 3. Those with mental retardation and those currently suffering from severe physical and neurological diseases; 4. Meet the diagnostic criteria for previous substance abuse and substance dependence; 5. Contraindications for magnetic resonance imaging; 6. No immunosuppressants or other drugs that affect the immune system have been taken for at least half a year; 7. Pregnant or menstruating women; 8. BMI>25.

Design outcomes

Primary

MeasureTime frame
Inflammatory factors (IL-6, TNF-a, IL-1ß, etc.);

Secondary

MeasureTime frame
DTI imaging (frontal - clasp - marginal bundle FA value);

Countries

China

Contacts

Public ContactLiping Chen

Guangzhou First People's Hospital

vickyliping2009@163.com+86 135 6041 8762

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026