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Prediction of the Efficacy and Related Mechanisms of SSRIs Combined with iTBS in Moderate to Severe Depression via fMRI

Prediction of the Efficacy and Related Mechanisms of SSRIs Combined with iTBS in Moderate to Severe Depression via fMRI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103165
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Major Depressive Disorder (MDD)

Interventions

SSRIS plus sham iTBS treatment group:Sham coil treatment
SSRIS +iTBS treatment group:Intermittent theta burst stimulation

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Participants will be included if they meet the following criteria: Diagnosis of depressive disorder confirmed by two board-certified psychiatrists and alignment with DSM-5 criteria for depressive disorders. A score of >=17 on the 17-item Hamilton Depression Rating Scale (HAMD). 2.Participants must be aged between 18 and 55 years, with both genders included. 3.Antidepressant treatment predominantly employs SSRIs (Selective Serotonin Reuptake Inhibitors) as monotherapy. 4.Participants must demonstrate the ability to adhere to at least one full cycle of iTBS (Intermittent Theta Burst Stimulation) treatment (10-day protocol) and complete all scheduled follow-up assessments.

Exclusion criteria

Exclusion criteria: 1.Participants with significant medical comorbidities, including but not limited to severe hepatic/renal insufficiency, cardiac disease, or malignant neoplasms, will be excluded. 2.Participants with severe traumatic brain injury (TBI), neurological disorders, or severe psychiatric illnesses including but not limited to schizophrenia, hysterical psychosis, bipolar disorder, etc., will be excluded. 3.Participants with a history of alcohol/substance misuse or those receiving polypharmacy involving multiple antidepressants will be excluded. 4.Subjects with any factors that may significantly affect MRI data quality, including but not limited to metal dental prostheses, metallic implants, or body piercings, will be excluded to preclude reliable image acquisition.

Design outcomes

Primary

MeasureTime frame
Depressive symptoms;Resting-State Functional Magnetic Resonance Imaging;

Countries

China

Contacts

Public ContactZhenyu Hu

Affiliated Kangning Hospital of Ningbo University

hzy86690952@163.com+86 574 26302501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026