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

Adolescent Depression Clinical Trial

Official title:

Medical Practitioner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325605
• Other study ID #: GRYY-LL-KJ2022-064
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2024
• Source: Tangshan Worker's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Depression
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	Tangshan Workers' Hospital	Tangshan	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Zhen-Hong Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD-24 scores	Final scores were interpreted as no depression (<20), mild or moderate depression (=20), and severe depression (=35)	4 times a week, for 8 consecutive weeks
Primary	TNF-a	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	IL-1ß	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	IL-6	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	DA	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	5-HT	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	COR	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	Serum miR-16	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days
Primary	Serum miR-195	About 5ml of fasting venous blood was collected in the morning, centrifuged at 3000rpm for 10mins, and the upper serum was collected. The levels of serum tumor necrosis factor-a(TNF-a), interleukin-1ß(IL-1ß), IL-6, dopamine(DA), 5-hydroxytryptamine(5-HT) and cortisol(COR) were measured by ELISA using an automatic biochemical analyzer(Dxc800, Beckman, USA). The relative expression levels of serum miR-16 and miR-195 were determined by PCR. All measurements were strictly conducted by laboratory specialists following the instructions of the instruments and kits.	7 consecutive days