A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression.

Background. Effectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up. Method. Fifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n = 29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (≥50% reduction in HAMD) and remission (HAMD≤8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups. Results. Overall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group x time interaction (p =0.09) or group main effect (p = 0.85); the mean difference in HAMD change scores was - 0.3 (95 % CI - 3.4 to 2.8). At end-of-treatment time-point, 32 % of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI -0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters. Conclusions. Adjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.