• Mood Disorders
• Psychiatry Clinical Trials

• Psychiatry
• Mood Disorders
• Psychiatry Clinical Trials

For patients with treatment-resistant depression, long-term maintenance therapy with 1 weekly session of repetitive transcranial magnetic stimulation (rTMS) shows promise in preventing relapse in patients who respond to acute rTMS treatment. René Benadhira, MD, Unité de Recherche Clinique, Paris, France, presented preliminary results on a 1-year, double-blind, randomized controlled trial evaluating the efficacy of rTMS as maintenance therapy for patients with treatment-resistant depression.

The study consisted of 2 phases. In Phase 1, all patients received acute treatment with active high-frequency stimulation with rTMS during 4 blocks of 5 consecutive working days in an open-label phase of the trial. In Phase 2, patients who responded to acute treatment were randomized to maintenance therapy with sham or rTMS for 11 months. During Phase 2, the rhythm of rTMS sessions was gradually reduced to 3 sessions per week for 2 weeks, 2 sessions per week for the following 2 weeks, 1 session per week for the third month (M3) and fourth (M4), and then 1 session every 2 weeks for the last 8 months (M5 to M12). The primary outcome was improvement in symptoms of depression based on the 17-item Hamilton Depression Rating Scale (HAM-D). Responders were defined as those who achieved >49% reduction in HAM-D score from baseline.

Prof. Benadhira reported on the intermediate analysis of 69 patients. Most patients were female (n=43) and had unipolar depression (79.7%). The mean age was ∼51 years; the mean duration of education was ∼11 years; and the mean duration of illness was tilde;8 years. At baseline, the mean HAM-D score was 22.59. Results of the Phase 1 part of the trial showed that 33 (48%) patients responded to acute treatment with rTMS, 15 (22%) achieved partial response, and 2 (2.9%) achieved remission (ie, defined as HAM-D <8). Of the 33 responders, 14 agreed to participate in Phase 2 of the trial and were randomized to active rTMS (n=9) or sham treatment (n=5). Results of Phase 2 showed significant difference in HAM-D score between active rTMS and sham at 4, 5, and 6 months (Table 1). Additional assessments of efficacy also showed significant differences between active rTMS and sham.

Overall, the Phase 2 part of the study showed that all patients treated with rTMS maintained a response to treatment during the 4 weeks of further treatment. At 4, 5, and 6 months, patients on maintenance rTMS had significant improvement in depressive symptoms when compared with patients in the sham treatment group, as shown by the HAM-D scores. This significant difference in change in HAM-D score disappeared starting at Month 7, which, according to Prof. Benadhira, was due to the insufficient number of treatment sessions (ie, 1 session every 2 weeks).

These results suggest that maintenance therapy with 1 session of rTMS per week may be able to prevent relapses in these patients, said Prof. Benadhira, who also emphasized the need for a larger study to confirm the result.

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