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The efficacy and mechanism of accelerated iTBS on suicidal ideation in depressed patients

The efficacy and mechanism of accelerated iTBS on suicidal ideation in depressed patients: a randomised controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068954
Enrollment
Unknown
Registered
2023-03-02
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

major depressive disoder, bipolar disorder

Interventions

Group A:True stimulation left DLPFC+LC treatment
Group B:True stimulation left DLPFC+false stimulation left LC treatment

Sponsors

First Affiliated Hospital of Ji'nan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 10-45 years, no gender limit; 2. Meet the DSM-5 criteria for major depressive disorder or bipolar disorder (type I or II) depressive episodes; 3. 24 Hamilton Depression Scale scores > 20 points, and item 3 > 2 points; 4. Score of Young's Mania Scale < 6; 5. The answer to question 4 (active suicidal ideation) or question 5 (passive suicidal ideation) of the Baker Suicide Ideation Scale is ‘’Yes’’; 6. Passed the TMS safety assessment questionnaire; 7. Han nationality, right-handed; 8. As the subject voluntarily, the patient himself or her legal guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other mental disorders along the comorbidity axis I; 2. Patients with a history of psychoactive substance abuse, alcohol abuse or dependence; 3. Patients with severe physical diseases and organic brain diseases; 4. Received electroconvulsive therapy or transcranial magnetic stimulation after onset of the disease; 5. Pregnant or lactating patients; 6. Those who cannot cooperate or have magnetic resonance examination taboo (such as heavy metal implants or wearing dentures or orthotics with teeth); 7. Failure to follow the research protocol.

Design outcomes

Primary

MeasureTime frame
Beck Scale for Suicide Ideation;Columbia Suicide Severity Rating Scale;MATRICS Consensus Cognitive Battery, MCCB;Das-Naglieri: Cognitive Assessment System, DN:CAS;NAA/Cr ratios of prefrontal cortex;NAA/Cr ratios of basal ganglia;NAA/Cr ratios of cerebellum;mI/Cr ratios of prefrontal cortex;mI/Cr ratios of basal ganglia;mI/Cr ratios of cerebellum;Cho/Cr ratios of prefrontal cortex;Cho/Cr ratios of basal ganglia;Cho/Cr ratios of cerebellum;Brain volume and cortex;Functional connection of brain;Stroop Color-Word Test;Wsiconsin Card Sorting Test, WCST;Trail Making Test-part B, TMT-B;

Secondary

MeasureTime frame
Hamilton Depression Rating Scale;Young Mania Rating Scale;Hamilton Rating Scale for Anxiety;Beck Hopelessness Scale;Montgomery-Asberg Depression Rating Scale;Near-infrared spectroscopy;

Countries

China

Contacts

Public ContactJia Yanbin

First Affiliated Hospital of Ji'nan University

932860852@qq.com+86 130 5954 0908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 21, 2026