NCT06325605

Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression

Medical Practitioner

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Zhen-Hong Hu · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke).

Conditions

• Adolescent Depression

Interventions

Type	Name	Description
DRUG	Bifidobacterium	3 capsules, 3 times a day, for 8 consecutive weeks
DEVICE	High-frequency rTMS	In the rTMS treatment, the transcranial magnetic stimulation device with an "8"-shaped coil with a diameter of 70mm was placed on the dorsolateral area of the left prefrontal lobe of the patient. The motor threshold was set to 90%. A 10-Hz pulse sequence was applied for 4 secs followed by a 20 secs interval. 10 pulses per train were used, and the total stimulation time was 30mins per day, 4 times a week, for 8 consecutive weeks.
DRUG	Escitalopram Oxalate	Oral escitalopram oxalate. The initial dose was 5mg/d, for 7 consecutive days. The dose was increased to 10 mg/d according to the tolerance of the patients for another 7 consecutive days, and then to 20 mg/d according to the patient's condition and tolerance for 8 weeks

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: China