Bifidobacterium with high-frequency transcranial stimulation adolescent depression
| ISRCTN | ISRCTN16752763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16752763 |
- Submission date
- 14/03/2025
- Registration date
- 19/03/2025
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
To explore the efficacy and safety of Bifidobacterium combined with high-frequency transcranial magnetic stimulation in the treatment of adolescent depression.
Who can participate?
Adolescents aged 13-18 years old with depression who were admitted to the participating hospital
What does the study involve?
Participants were randomly divided into two groups to compare treatment effects after eight weeks.
What are the possible benefits and risks of participating?
Bifidobacterium combined with high-frequency transcranial magnetic stimulation is effective in the treatment of adolescent depression with a favorable safety profile.
Where is the study run from?
Wenzhou Seventh People's Hospital, China
When is the study starting and how long is it expected to run for?
January 2022 to October 2022
Who is funding the study?
Wenzhou Seventh People's Hospital, China
Who is the main contact?
Cong-Cong Chen, chen33congc9ong3@yeah.net
Contact information
Public, Scientific, Principal Investigator
Wenzhou Seventh People's Hospital, 552 Xishan East Road, Ouhai District
Wenzhou, Zhejiang
325000
China
| Phone | +86 0577-86188516 |
|---|---|
| chen33congc9ong3@yeah.net |
Study information
| Study design | Single-center intervention single-blind randomized-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy and safety of bifidobacterium combined with high-frequency transcranial magnetic stimulation in the treatment of adolescent depression: a preliminary randomized controlled trial |
| Study objectives | Bifidobacterium combined with high-frequency transcranial magnetic stimulation is effective in the treatment of adolescent depression |
| Ethics approval(s) |
Approved 26/08/2021, Wenzhou Seventh People's Hospital (Room 218, 2nd floor, outpatient buidling, 158 Xueshiqian, Panqiao street, Ouhai District, Wenzhou City, Zhejiang Province, 325000, China; +86 0577-89870004; wqyllwyh@126.com), ref: EC-20210826-03 |
| Health condition(s) or problem(s) studied | Bifidobacterium combined with high-frequency transcranial magnetic stimulation in the treatment of adolescent depression |
| Intervention | A total of 100 patients were selected, and divided into the experimental group(n=50) and the control group(n=50) using a random number table. Patients in the experimental group were treated with Bifidobacterium and high-frequency transcranial magnetic stimulation (rTMS), and those in the control group were treated with oral escitalopram oxalate. After 8 weeks of treatment, the Hamilton Rating Scale for Depression (HAMD-24) score, serum inflammatory factors, neuroendocrine indicators and miRNAs were determined in both groups. The random double-blind principle was strictly followed during the whole process of the study. |
| Intervention type | Mixed |
| Primary outcome measure | Depression symptoms measured using the Hamilton Rating Scale for Depression (HAMD-24) score before and after treatment |
| Secondary outcome measures | The following secondary outcome measures are assessed before and after treatment: 1. The levels of serum inflammatory factors and neuroendocrine indicators: 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). 2. The relative expression levels of serum miR-16 and miR-195 were measured using PCR 3. Remission rate measured using HAMD scores (difference in scores before and after treatment/score before treatment × 100%) 4. The incidence rate of adverse reactions measured using events reporting and calculated by dividing the number of patients with adverse reactions by the total number of patients |
| Overall study start date | 01/01/2022 |
| Completion date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Aged 13-18 years old 2. Met the diagnostic criteria for depression in the International Classification of Disease-10 (ICD-10) 3. With a total score of the Hamilton Rating Scale for Depression (HAMD-24) ≥20 in the initial assessment 4. Who were right-handed |
| Key exclusion criteria | 1. With a definite diagnosis of other mental disorders in the past 2. With a past or current history of manic episodes 3. With a past or current history of severe physical diseases 4. Who used antidepressants, mood stabilizers, steroids, anti-inflammatory drugs, antibiotics, and immunomodulators in the past 1 month 5. Who used lactic acid bacteria products for ≥7 days in the past 1 month 6. With a history of alcohol or psychoactive substance abuse within the last 3 months 7. With contraindications for RTMS, including but not limited to intracranial metal foreign bodies, cardiac pacemakers, and ear hearing aids 8. Complicated with organic brain diseases, epileptic diseases, and severe physical diseases |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 31/10/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Wenzhou, Zhejiang
325000
China
Sponsor information
Hospital/treatment centre
552 Xishan East Road, Ouhai District
Wenzhou, Zhejiang
325000
China
| Phone | +86 0577-86188516 |
|---|---|
| wqyllwyh@163.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned for publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Cong-Cong Chen (chen33congc9ong3@yeah.net). |
Editorial Notes
14/03/2025: Study's existence confirmed by the Wenzhou Seventh People's Hospital Ethics Committee Review.
