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.
Phase 3
- Conditions
- Major depressive disorder (Monopolar depression)
- Registration Number
- JPRN-UMIN000007794
- Lead Sponsor
- Kinkou Hospital, Kanagawa Psychiatric Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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