Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial

Stefanie Desmyter, Romain Duprat, Chris Baeken, Sara Van Autreve, Kurt Audenaert, Kees van Heeringen, Stefanie Desmyter, Romain Duprat, Chris Baeken, Sara Van Autreve, Kurt Audenaert, Kees van Heeringen

Abstract

Objectives: We aimed to examine the effects and safety of accelerated intermittent Theta Burst Stimulation (iTBS) on suicide risk in a group of treatment-resistant unipolar depressed patients, using an extensive suicide assessment scale. Methods: In 50 therapy-resistant, antidepressant-free depressed patients, an intensive protocol of accelerated iTBS was applied over the left dorsolateral prefrontal cortex (DLPFC) in a randomized, sham-controlled crossover design. Patients received 20 iTBS sessions over 4 days. Suicide risk was assessed using the Beck Scale of Suicide ideation (BSI). Results: The iTBS protocol was safe and well tolerated. We observed a significant decrease of the BSI score over time, unrelated to active or sham stimulation and unrelated to depression-response. No worsening of suicidal ideation was observed. The effects of accelerated iTBS on mood and depression severity are reported in Duprat et al. (2016). The decrease in suicide risk lasted up to 1 month after baseline, even in depression non-responders. Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham stimulation and unrelated to depression response. Further sham-controlled research in suicidal depressed patients is necessary. (Clinicaltrials.gov identifier: NCT01832805).

Keywords: depression; repetitive transcranial magnetic stimulation; suicidal ideation; suicide; therapy-resistant depression; theta burst stimulation.

Figures

Figure 1
Figure 1
Flowchart of the iTBS-sham-controlled cross-over protocol. Patients were randomized to two groups: group A (n = 22) received iTBS during the first week and sham in the second week and group B (n = 24) was administered sham stimulation during the first and iTBS in the second week. Stimulation parameters: 110% resting MT (rMT), 1620 pulses per session in 54 bursts of three with a train duration of 2 s and an intertrain interval of 8 s; five sessions per day during 4 days per week. Evaluations were carried out at four time-points: at baseline (T1), after the first week of stimulation (T2), after the second week of stimulation (T3) and 2 weeks after the last stimulation, i.e., 1 month after baseline (T4). iTBS, intermittent Theta Burst Stimulation; MT, Motor Threshold.
Figure 2
Figure 2
Beck Scale of Suicide ideation (BSI) scores before and after active and sham treatment. Graphical representation of the BSI mean scores with Time (baseline (T1), after 1 week of stimulation (T2), after finishing the treatment protocol (T3) and 2 weeks later (T4)) as within-subjects variable, and Order (sham > active vs. active > sham) as between-subjects factor. *Indicates significant difference.
Figure 3
Figure 3
BSI score in Hamilton Depression Rating Scale (HDRS)- responders and non-responders. Graphical representation of the BSI mean scores with Time (baseline (T1), after 1 week of stimulation (T2), after finishing the treatment protocol (T3) and 2 weeks later (T4)) as within-subjects variable and HDRS responders on T4 as between-subjects factor. *Indicates significant difference.

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