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Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression

Therapeutic Effects of Theta-Burst Stimulation on severity of depression and cognitive functions in major depression - Antidepressant efficacy of TBS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011856
Enrollment
120
Registered
2013-09-25
Start date
2012-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

A treatment option for refracfory depression

Interventions

cTBS (1800): right DLPFC, 1800 pulses/session, 10 sessions/ 2 weeks iTBS (1800): left DLPFC, 1800 pulses/session, 10 sessions/ 2 weeks cTBS (1800) + iTBS (1800): cTBS over right DLPFC and iTBS over le
randomized sequences in determining which side to be started with Sham controlled group: figure-of-eight coil targeted at either side of DLPFC (randomized) with 90 degree against skull

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Major Depressive Disorder(MDD), no substance abuse and personality disorders (based on DSM-IV) Meet medication-resistant depression: fail to respond to at least 2 trials of adequate antidepressant treatments (dosage and duration) At least moderate depression before TBS: Clinical Global Index of severity >=4 and 17-item Hamilton Depression Rating Scale (HDRS-17)>= 18

Exclusion criteria

Exclusion criteria: No major systemic illness(e.g.,severe arrhythmia);no neurological disorders(e.g., neuro-stimulators, stroke, seizure, traumatic brain injury); Not in pregnant; No brain implants; No pacemakers; No brain surgery past history

Design outcomes

Primary

MeasureTime frame
Maudsley staging scoring questionnaires (baseline); Depressive symptoms: Hamilton Depression Rating Scale-17 (HDRS-17), Depression Subscales for Somatic Symptoms (DSSS), Short-form McHill Pain Questionnaire(MPQ) and Visual Analogue Scores (VAS) Manic symptoms: Young Mania Rating Scales (YMRS) Quality of life: MOS SF-12 quality of life rating scales

Secondary

MeasureTime frame
Nerocognitive testings will be also performed twice, baseline and 2 weeks post-treatment, to check their attention (Test for Attentional Performance) and executive function (Wisconsin Card Sorting Tests). 3T MRI and 18F-FDG PET

Countries

Asia(except Japan)

Contacts

Public ContactCheng-Ta Li

Taipei Veterans General Hospital, Taiwan Psychiatry

on5083@msn.com+81-188628757027

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026