A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, followed by a semi-crossover open trial of rTMS.

A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, followed by a semi-crossover open trial of rTMS. - A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007794

Enrollment

Registered

2012-04-23

Start date

2012-05-01

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

Major depressive disorder (Monopolar depression)

Interventions

Navigation-guided high-frequency rTMS TMS coil: air-cooled figure-of-eight coil site: left dorsolateral prefrontal cortex (lt.DLPFC) frequency: 10Hz (4sec. train, 26sec. interval) intensity: 100%

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 20-75 years-old, male and female, inpatients, self-sustained ADL 2. Capability of informed consent 3. DSM-IV-TR diagnosis of major depressive disorder, single episode (296.2x) or recurrent (296.3x) 4. Current episode duration: more than 8 weeks and less than 5 years 5. Hamilton Scale for Depression 17-item score: more than 14 6. Medication resistance (insufficient clinical benefit to more than 2 medication trials) or medication intolerance (intolerant to more than 2 medication trials) during current episode

Exclusion criteria

Exclusion criteria: 1. Absolute contraindications of rTMS (inplanted medical devices or intracranial ferromagnetic material) 2. Relative contraindications of rTMS, including a) pregnancy, b) seizure disorders or paroxysmal EEG abnormality, and c) medications known to lower seizure threshold 3. Other current Axis I disorders 4. Suicidality (Ham-D suicidality score more than 3) 5. Psychotic features during current episode 6. Instability of physical conditions 7. History of neurologic disorders 8. Previous treatments with rTMS and VNS, and treatment history of ECT within a year

Design outcomes

Primary

Measure	Time frame
1) Hamilton Depression Rating Scale (Ham-D) 17items and 24items: weekly evaluation 2) rTMS side effects questionnaire, which was translated in Japanese from original version of Center for Noninvasive Brain Stimulation, Harvard Medical School.: evaluated every rTMS session	—

Secondary

Measure	Time frame
3) Beck Depression Inventry II (BDI-II): weekly evaluation 4) State-Trait Anxiety Inventory (STAI): weekly evaluation 5) Neuropsychological Testings (Verbal Fluency Test; VFT, Wisconsin Card Sorting Test; WCST, Color Stroop Test; CST, Trail Making Test; TMT): biweekly evaluation	—

Countries

Japan

Contacts

Public ContactMotoaki Nakamura

Kinkou Hospital, Kanagawa Psychiatric Center Laboratory of Neuromodulation

motoaki@motoaki.com045-822-0241

Outcome results

None listed

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