Efficacy of two intensive and spaced protocols of theta burst transcranial magnetic stimulation in treatment-resistant depression: a double-blind randomized trial

Introduction Depression is the disease with greatest burden of disability. Despite pharmacological options, up to 30% depressions are considered resistant treatment (RTD). Theta burst transcranial magnetic stimulation (TBS) on dorsolateral prefrontal cortex allows application shorter protocols and longer-lasting effects than conventional TMS. Its implementation in Public Health System requires design efficient, cost-effective accessible for patients. Objectives The objective this project assess efficacy safety two intensive spaced (unilateral bilateral) 1800 pulses TBS compared sham outpatients unipolar bipolar TRD a public hospital. Methods This 1st double-blind placebo-controlled RCT Spain. It now recruitment phase. Patients receive total 22 sessions 6 weeks: 5 days/week 2nd weeks (10 sessions) 3 sessions/week following (12 sessions). randomized into three groups: i) bilateral, ii) left unilateral, iii) sham. main variable change HDRS-17 score at end baseline. results were analyzed general linear model HDRS, using time as intrasubject factor randomization group intersubject factor, resistance (Maudsley Score) diagnosis (bipolar, unipolar) covariates. Results Preliminary from 13 participants (nbil=4, nuni=4, nsham=5) reveal significant effect (group x time) HDRS (p= 0.020) no influence Maudsley Score or diagnosis. bilateral presented greater decrease mean difference 4,38 points [CI95% 0,17-8,58), (p=0.043)] respect unilateral 8.23 4,24-12,21)(p =0.001)] group. Table 1: Sample description. Data shown means standar deviations. In bold diferences p<0,05. Bilateral (n=4) Unilateral Sham (n=5) Age [M (SD)] 55,50 (5,80) 48,50 (16,86) 56,40 (5,86) Male: Female [n] 0:4 2:2 3:2 Depression:Bipolar disorder 3:1 4:1 Length depresive episode (months) 12,00 (4,08) 16,50 (6,61) 15,00 (5,83) Current number antidepressants 2,00 (0,82) 1,75 (0,50) 2,60 (0,55) 7,00 (1,82) 8,75 (1,5) 7,90 (1,30) Basal basal 16,00 19,75 (4,03) 20,40 (3,21) Final 5,75 (3,30) 10,75 (3,10) 17,80 (2,49) Response /Remission[n (%)] 3: (75%) 2: 0( 50:0%) 0: 0 ( 0%) Image: Conclusions demonstrate preliminary relative Disclosure Interest None Declared