A double-blind sham controlled study of right prefrontal repetitive transcranial magnetic stimulation (rTMS): Therapeutic and cognitive effect in medication free unipolar depression during 4 weeks

Background: Transcranial magnetic stimulation (TMS) has become a therapeutic tool in psychiatric diseases. Methodology: The objective was to evaluate the efficacy of TMS in unipolar depression: the percentage of responders (> 50% HDRS reduction) and remission HDRS score <= 8, after four weeks of active TMS treatment in depressed patients free of any antidepressive agent versus placebo-TMS. Results: 27 patients were randomized in two groups: rTMS (N=11) versus sham TMS (N=16). Statistical differences were detected between sham and TMS treated groups on remission (0/16 versus 4/11 p=0.032, 1/16 versus 6/11 0.028 and 1/16 versus 7/11 p=0.011 at day 14, day 21 and day 28, respectively) and on response (2/16 versus 5/11 at day 14 (NS), 2/16 versus 7/11 p=0.0115 at day 21 and 1/16 versus 7/11 (p=0.025) day 28, respectively, using the exact Fisher test). Significant differences were observed between day 1 versus day 8 (p < 0.01), day 15, day 21 and day 28 (p < 0.001) in TMS group and only versus day 21 (p < 0.01) and day 28 (p < 0.05) for the sham group. ANOVA comparison between TMS and sham groups was significant at day 14 and day 28 (< 0.05). Limitations: The few number of patients. Conclusion: Our study has shown an efficacy of right rTMS in free medication unipolar depression over a month. Nevertheless, number of patients included is limited and multicentric studies will be necessary to specify the antidepressive action of TMS. (c) 2005 Elsevier Inc. All rights reserved.