A Randomized Double-Blind Controlled Clinical Trial on the Impact of Stanford Neuromodulation Therapy on Inflammatory Factors in Depression.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600126030

Enrollment

Unknown

Registered

2026-06-02

Start date

2026-01-22

Completion date

Unknown

Last updated

2026-06-08

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

Conditions

Depression

Interventions

active Stanford neuromodulation therapy group:Stanford neuromodulation therapy

sham Stanford neuromodulation therapy group:sham stimulation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), without psychotic symptoms, as confirmed by two or more attending psychiatrists. 2. Aged 18–65 years, regardless of gender. 3. Hamilton Depression Rating Scale 17-item (HAMD-17) score > 17. 4. Patients currently receiving stable treatment with SSRIs, with no changes in medication during the 4 weeks prior to this study and throughout the treatment and evaluation periods. 5. Right-handed. 6. Willing to actively cooperate with treatment after fully understanding the safety of iTBS therapy and signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to rTMS treatment or fMRI scanning. 2. Patients with a lifetime or current diagnosis of other mental disorders based on the DSM-5. 3. Depression caused by other psychoactive substances or non-addictive substances. 4. Conditions or medications that significantly affect inflammation levels: such as active autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus), active infections (within the past 4 weeks), active tumors, recent surgery or trauma (within the past 3 months), or obesity (BMI >= 30 kg/m²). 5. Participants who have received Stanford Neurostimulation Therapy prior to enrollment, have undergone electroconvulsive therapy within the past six months, or have been unresponsive to the aforementioned treatment methods. 6. Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Levels of Inflammatory factors in the blood;Montgomery-?sberg Depression Rating Scale;Hamilton Depression Rating Scale, 17-item version;Clinical Global Impression Scale;	—

Countries

China

Contacts

Public ContactZhang Lili

Hebei Provincial Mental Health Center

beckyh2019@163.com+86 176 2359 7204

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026