Medical Practitioner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HAMD-24 scores
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bifidobacterium (Drug)
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.
干预措施: High-frequency rTMS (Device)
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.
干预措施: Escitalopram Oxalate (Drug)
结局指标
主要结局
HAMD-24 scores
时间窗: 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)
TNF-α
时间窗: 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.
DA
时间窗: 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.
IL-6
时间窗: 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.
IL-1β
时间窗: 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-HT
时间窗: 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.
Serum miR-195
时间窗: 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.
COR
时间窗: 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.
Serum miR-16
时间窗: 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.
次要结局
未报告次要终点
研究者
Zhen-Hong Hu
Associate chief physician
Tangshan Worker's Hospital