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A study of the efficacy of individualized acTBS based on amygdala resting-state functional connectivity in depressed patients with anxiety distressing features

A study of the efficacy of individualized acTBS based on amygdala resting-state functional connectivity in depressed patients with anxiety distressing features

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100136
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-06-09
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Major depressive disorder

Interventions

Individualized target groups:1. Subjects were enrolled and treated with escitalopram oxalate, the dose of which was increased from 5 mg/day to 10 mg/day over 7 days, and subsequently
2. Subjects were required to maintain escitalopram oxalate at a dose of 10 mg/day throughout the study period
Received 5 consecutive days of accelerated continuous theta wave pulse stimulation (acTBS) based on individualized target localization of amygdala-right dorsolateral prefrontal cortex functional conne
Fixed target group:1. Subjects were enrolled and treated with escitalopram oxalate, the dose of which was increased from 5 mg/day to 10 mg/day over 7 days, and subsequently, subjects were required to
2. Received 5 consecutive days of accelerated continuous theta wave pulse stimulation (acTBS) with fixed target localization (fixed MNI coordinates)
Sham group:1. Subjects were enrolled and treated with escitalopram oxalate, the dose of which was increased from 5 mg/day to 10 mg/day over 7 days, and subsequently, subjects were required to maintain
2. Half of the subjects received 5 consecutive days of pseudostimulation based on individualized targets, and the other half received 5 consecutive days of pseudostimulation based on fixed

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Meet the DSM-5 diagnostic criteria for anxiety depression; 2. Never take antidepressants before enrollment, terminate the medication for more than 14 days (patients taking fluoxetine treatment should stop taking the medication for at least 28 days); 3. HAMD-17 level >= 18 points and meet the total HAMD anxiety/somatic factor score >= 7 points (including entry 10-mental anxiety, entry 11-somatic anxiety, entry 12-gastrointestinal symptoms, entry 13-general symptoms, entry 15-suspicion, entry 17-self-awareness, a total of 6 items), and the anxiety level of the current episode HAMA >= 14 points; 4. Age 18-45 years old, right-handed, and with an education level of junior high school or above; 5. Gender is not limited; 6. Patients voluntarily participated and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Current or prior diagnosis of a major psychiatric disorder other than a depressive disorder consistent with the DSM-5, such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, obsessive-compulsive disorders, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse, personality disorders, or history of depressive disorders secondary to other psychiatric disorders; 2. Neurologic disorders, such as brain tumors, cerebrovascular events, epilepsy, neurodegenerative diseases, or previous brain surgery; 3. standard contraindications to MRI (e.g., immovable metal objects in and around the body, claustrophobia) or pregnant or lactating women; 4. Electroconvulsive therapy in the 3 months prior to enrollment; 5. any other circumstance that, in the opinion of the investigator, makes participation in the study unsuitable.

Design outcomes

Primary

MeasureTime frame
HAMD-17 subtraction before and after treatment (baseline vs 1 week);

Secondary

MeasureTime frame
HAMD-17 effective rate at week 1 (effective: >=50% reduction in HAMD-17 score from baseline) ;Trend in HAMD score reduction from baseline for each day of treatment ((HAMD-17pre-HAMD-17post)/ HAMD-17pre*100%);HAMD-17 remission rate by time point (remission HAMD-17 score <= 7);

Countries

China

Contacts

Public ContactGang Wang

Beijing Anding Hospital, Capital Medical University

adgangwang@163.com+86 139 1169 5727

Outcome results

None listed

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