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Completed

NCT Number: NCT06325605

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

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).

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Key information

Conditions

Adolescent Depression

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tangshan Workers' Hospital

Tangshan, Hebei, 063003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium

Drug

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

Other names: 0.07g/capsule, approval number: Guo Yao Zhun Zi S10950032, Shanghai Sine Pharmaceutical Co., Ltd.

High-frequency rTMS

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.

Escitalopram Oxalate

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

Other names: manufacturer: Sichuan Kelun Pharmaceutical Co., Ltd.; approval No.: Guo Yao Zhun Zi H20080788

Primary outcomes

  1. HAMD-24 scores

    Time frame: 4 times a week, for 8 consecutive weeks

    Final scores were interpreted as no depression (<20), mild or moderate depression (≥20), and severe depression (≥35)

  2. TNF-α

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  3. IL-1β

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  4. IL-6

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  5. DA

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  6. 5-HT

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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. COR

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  8. Serum miR-16

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

  9. Serum miR-195

    Time frame: 7 consecutive days

    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-α(TNF-α), interleukin-1β(IL-1β), 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.

Sponsors and collaborators

Lead sponsor

Zhen-Hong Hu

Other

Registry information

Official study title

Medical Practitioner

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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