Skip to content

Bifidobacterium with high-frequency transcranial stimulation adolescent depression

Efficacy and safety of bifidobacterium combined with high-frequency transcranial magnetic stimulation in the treatment of adolescent depression: a preliminary randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16752763
Enrollment
116
Registered
2025-03-19
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bifidobacterium combined with high-frequency transcranial magnetic stimulation in the treatment of adolescent depression Mental and Behavioural Disorders

Interventions

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 Bifid

Sponsors

Wenzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Depression symptoms measured using the Hamilton Rating Scale for Depression (HAMD-24) score before and after treatment

Secondary

MeasureTime frame
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-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). 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

Countries

China

Contacts

Public ContactCong-Cong Chen
chen33congc9ong3@yeah.net+86 0577-86188516

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026