As they alleviate major depressive disorder, antidepressant therapies may improve associated sleep disturbances, but may also have inherent sedating or activating properties. We examined sleep changes during a multicenter, sham-controlled, trial of transcranial magnetic stimulation (TMS) therapy for pharmacoresistant MDD. Medication-free outpatients (N=301) were randomized to receive active (N=155) or sham (N=146) TMS for 6 weeks. Depression severity was rated with the Montgomery-Asberg Depression Rating Scale, the 24-item Hamilton Depression Scale (HAMD), and the Inventory of Depressive Symptoms-Self Report (IDS-SR). Assessments were performed at baseline, 2, 4, and 6 week time points. Sleep was assessed using the HAMD and IDS-SR sleep factors; comparison between treatment groups employed ANCOVA model. No significant differences were identified between the active and sham treatment groups in either the HAMD or IDS-SR sleep factor scores at any time during treatment. Sleep difficulty as an adverse event over the length of the study did not differ between active and sham treatment. Stratified by end of acute treatment responder status, there was a statistically significant improvement in both the HAMD sleep factor score and the IDS-SR sleep factor during acute treatment in both the active and sham treatment conditions. TMS exerts no intrinsic effect upon sleep in patients with MDD.
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