A treatment option for Medication-resistant depression
Conditions
Interventions
Bilateral DMPFC prolonged intermittent theta-burst stimulation (piTBS) group (2 sessions/hemisphere/day, 5 days/week,total 2 weeks)
80% active motor threshold, 1800 pulses/session
Bilateral DMPFC 20Hz-rTMS group (2 sessions/hemisphere/day, 5 days/week,total 2 weeks)
100% resting motor threshold, 2000 pulses/session
Sham group (2 sessions/hemisphere/day, 5 days/week, total 2 weeks)
randomly divided to half with piTBS and half with rTMS parameters using a sham coil.
Sponsors
Taipei Veterans General Hospital, Taipei, Taiwan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) adult patients with the relapse of major depressive episode (2) Severity: 17 items HDRS >=18; CGI>=4 (3) Poor response to at least one antidepressant (4) keep the antidepressant and its dosage at least 4 weeks before entering the trial; no adjustment of antidepressant during the trial.
Exclusion criteria
Exclusion criteria: Patients with schizophrenia, bipolar I&II disorder, organic mental disorder and major physical illness; with brain implants or cardiac pacemakers; pregnancy; or who having strong suicidal risk; poor response to previous ECT or 10Hz left DLPFC rTMS/piTBS; claustrophobia for MRI screening; patients who cannot cooperate the trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changing of17-items Hamilton Depression Rating Scale (HDRS-17,week-2 vs. baseline) in response to the 2-week DMPFC brain stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| baseline and the changing of resting state functional and structural connectivity, EEG, paired-pulse TMS-EEG; Cognitive function; Response rate and remission rate, evaluated by HDRS-17; the changing of anxiosomatic cluster symptoms derived from HDRS-17, dysphoric cluster symptoms derived from HDRS-17, Montgomery-Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale(HAM-A), depression subscale and somatic subscale of Depression and Somatic Symptoms Scale (DSSS), Clinical Global Index (CGI),Young Mania Rating Scale (YMRS),Rumination response scale (RRS), Snaith-Hamilton Pleasure Scale (SHAPS), UCLA loneliness scale, Difficulties in Emotion Regulation Scale (DERS), Taiwan Cognition. Questionnaire (TCQ); the predictive values of Maudsley Staging method for refractoriness and TRD severity scale (TRDSS). | — |
Countries
Asia(except Japan)
Contacts
Public ContactChih-Ming Cheng
Taipei Veterans General Hospital, Taipei, Taiwan Department of Psychiatry
Outcome results
None listed