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

View Article: PubMed Central - PubMed

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).

No MeSH data available.


Related in: MedlinePlus

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.
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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.

Mentions: Fifty therapy-resistant antidepressant-free patients were included (35 females), with a mean age of 41.90 years (SD = 11.77). Patients with the following conditions were excluded: psychotic symptoms, history of epileptic insult, cerebral surgery, having a pacemaker, having had ECT, alcohol dependence and patients who committed a suicide attempt within 6 months before the start of the study. Bipolar and psychotic depressed patients were not included. The 21-items Beck Scale for Suicide Ideation (BSI) was used to assess the intensity of the patients’ suicide risk. The BSI is a self-rating scale that measures the current intensity of the patients’ suicidal ideations, intentions and plans to commit suicide. Each item consists of three options graded according to suicidal intensity ranging from 0 to 2. The total score is yielded by the sum of the ratings for the first 19 items, ranging from 0 to 38. The BSI consists of five screening items. Three items assess the wish to live or the wish to die and two assess the desire to attempt suicide. If the subject reports any active or passive desire to commit suicide, then 14 additional items are administered. These consist of suicidal risk factors such as the duration and frequency of ideation, sense of control over making an attempt, number of deterrents, and amount of actual preparation for a contemplated attempt. Two additional items record incidence and frequency of previous suicide attempts (Beck et al., 1988; Beck and Steer, 1991). There were four time-points for evaluation at which depression severity was evaluated using the HDRS, assessed by a trained, but independent rater who was blind to the treatment condition (active or sham). The BSI was administered to evaluate suicide risk. These four time-points were: 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). Six months after baseline, patients were contacted to assess whether or not they had committed suicide. Patients were randomized to two groups: during the first week one group received the active stimulation and the other group started with the sham condition. They were switched to the other condition during the second week; see Figure 1 for a flowchart of the study design.


Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial
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.
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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.
Mentions: Fifty therapy-resistant antidepressant-free patients were included (35 females), with a mean age of 41.90 years (SD = 11.77). Patients with the following conditions were excluded: psychotic symptoms, history of epileptic insult, cerebral surgery, having a pacemaker, having had ECT, alcohol dependence and patients who committed a suicide attempt within 6 months before the start of the study. Bipolar and psychotic depressed patients were not included. The 21-items Beck Scale for Suicide Ideation (BSI) was used to assess the intensity of the patients’ suicide risk. The BSI is a self-rating scale that measures the current intensity of the patients’ suicidal ideations, intentions and plans to commit suicide. Each item consists of three options graded according to suicidal intensity ranging from 0 to 2. The total score is yielded by the sum of the ratings for the first 19 items, ranging from 0 to 38. The BSI consists of five screening items. Three items assess the wish to live or the wish to die and two assess the desire to attempt suicide. If the subject reports any active or passive desire to commit suicide, then 14 additional items are administered. These consist of suicidal risk factors such as the duration and frequency of ideation, sense of control over making an attempt, number of deterrents, and amount of actual preparation for a contemplated attempt. Two additional items record incidence and frequency of previous suicide attempts (Beck et al., 1988; Beck and Steer, 1991). There were four time-points for evaluation at which depression severity was evaluated using the HDRS, assessed by a trained, but independent rater who was blind to the treatment condition (active or sham). The BSI was administered to evaluate suicide risk. These four time-points were: 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). Six months after baseline, patients were contacted to assess whether or not they had committed suicide. Patients were randomized to two groups: during the first week one group received the active stimulation and the other group started with the sham condition. They were switched to the other condition during the second week; see Figure 1 for a flowchart of the study design.

View Article: PubMed Central - PubMed

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).

No MeSH data available.


Related in: MedlinePlus