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Randomized controlled trial on the efficacy of accelerated intermittent theta-burst stimulation for traumatic symptoms in adolescents with major depressive disorder

Randomized controlled trial on the efficacy of accelerated intermittent theta-burst stimulation for traumatic symptoms in adolescents with major depressive disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119133
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Traumatic symptoms with major depressive disorder

Interventions

Treatment Group:Accelerated intermittent theta burst stimulation (a-iTBS) administered five times daily for approximately three minutes per session, with 50-minute intervals between sessions, over fiv
Control Group:A sham stimulation with identical parameters but vertically positioned coils was employed as a control.

Sponsors

Beijing Huilongguan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 12–18 years, right-handed; 2. Meets ICD-10 diagnostic criteria for moderate depressive episode, with current depressive episode lasting at least 4 weeks; 3. HAMD (17-item) score: total >=17 points; 4. Positive CTQ scale screening, defined as: Emotional Abuse >=13 points OR Physical Abuse >=10 points OR Sexual Abuse =8 points OR Emotional Neglect >=15 points OR Physical Neglect >=10 points; 5. Stable use of a single selective serotonin reuptake inhibitor (SSRI) antidepressant for at least 15 days prior to enrolment (with no changes in drug type or dosage), or no prior use of any antidepressant medication; 6. Informed consent obtained from both the patient and guardian, with signed consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with bipolar disorder, alcohol use disorder, or substance use disorder; depressive states arising from other systemic diseases or organic brain lesions; 2. Presence of metallic implants such as dentures, aneurysm clips, cardiac pacemakers, or metallic fixations; 3. Individuals who have undergone systemic TMS or electroconvulsive therapy within the preceding three months; 4. Patients with treatment-resistant depression (TRD); 5. Presence of contraindications to TMS treatment; 6. Individuals currently undergoing systematic psychotherapy; 7. Those exhibiting severe agitation, risk of suicide or self-harm, or impulsive non-compliance.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD-17);

Secondary

MeasureTime frame
Patient Health Questionnaire-9 (PHQ-9);Generalized Anxiety Disorder-7 (GAD-7);Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5);Clinician Administered PTSD Scale (CAPS);International Trauma Questionnaire – Child and Adolescent Version (ITQ-CA);Ruminative Responses Scale (RRS);Deliberate Self-Harm Ideation Scale for Adolescents Revised Version (DSHI-AR);DSHI-AR (Thoughts);Ottawa Self-Injury Inventory – Addictive Subscale (OSI-Addictive);The Affective Reactivity Index (ARI-S / ARI-P);Brief Irritability Test (BITe);Blinding Assessment;Resting-state functional connectivity strength between prefrontal cortex and amygdala;High-frequency neural oscillation power in Magnetoencephalography (MEG);

Countries

China

Contacts

Public ContactXiaohong Li/Xinpeng Xu

Beijing Huilongguan Hospital, Capital Medical University

lxhshy2002@163.com+86 158 1040 2994

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026