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

NCT ID: NCT06325605

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Observation group

Patients in the observation group were treated with oral Bifidobacterium (0.07g/capsule, approval number: Guo Yao Zhun Zi S10950032, Shanghai Sine Pharmaceutical Co., Ltd.) 3 capsules, 3 times a day, for 8 consecutive weeks, and 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.

Group Type: EXPERIMENTAL

Bifidobacterium

Intervention Type: DRUG

3 capsules, 3 times a day, for 8 consecutive weeks

High-frequency rTMS

Intervention Type: DEVICE

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.

Control group

Patients in the control group were treated with oral escitalopram oxalate (manufacturer: Sichuan Kelun Pharmaceutical Co., Ltd.; approval No.: Guo Yao Zhun Zi H20080788). 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.

Group Type: ACTIVE_COMPARATOR

Escitalopram Oxalate

Intervention Type: DRUG

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

Interventions

Bifidobacterium

3 capsules, 3 times a day, for 8 consecutive weeks

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

0.07g/capsule, approval number: Guo Yao Zhun Zi S10950032, Shanghai Sine Pharmaceutical Co., Ltd.; manufacturer: Sichuan Kelun Pharmaceutical Co., Ltd.; approval No.: Guo Yao Zhun Zi H20080788

Eligibility Criteria

Inclusion Criteria

• aged 13-18 years old;
• met the diagnostic criteria for depression in the International Classification of Disease-10 (ICD-10);
• with a total score of the Hamilton Rating Scale for Depression (HAMD-24) ≥20 in the initial assessment;
• who were right-handed

Exclusion Criteria

• with a definite diagnosis of other mental disorders in the past;
• with a past or current history of manic episodes;
• with a past or current history of severe physical diseases;
• who used antidepressants, mood stabilizers, steroids, anti-inflammatory drugs, antibiotics, and immunomodulators in the past 1 month;
• who used lactic acid bacteria products for ≥7 days in the past 1 month;
• with a history of alcohol or psychoactive substance abuse within the last 3 months;
• with contraindications for rTMS, including but not limited to intracranial metal foreign bodies, cardiac pacemakers, and ear hearing aids;
• complicated with organic brain diseases, epileptic diseases, and severe physical diseases

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhen-Hong Hu

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Hong Hu

Associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tangshan Workers' Hospital

Tangshan, Hebei, China

Countries

China

Other Identifiers

GRYY-LL-KJ2022-064

Identifier Type: -

Identifier Source: org_study_id