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Abstract
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OBJECTIVES: Suicidality is a serious public health problem and is closely associated with the severity of depression. Despite extensive efforts, suicide rates remain unchanged, reinforcing the need for effective anti-suicidal therapies. We examined the effects of accelerated intermittent theta burst stimulation (iTBS) on suicidal status, risk factors for suicide, and severity of depressive symptoms.
METHODS: We present data from a quadruple-blind (patient, care provider, investigator, rater) sham-controlled crossover randomized clinical trial. During a six-week observation period, two weeks of stimulation were completed, each with 20 iTBS sessions of active and sham conditions. A suicide score was created using a composite of individual items from HAMD, MADRS and BDI-II scales. The severity of depression was determined by MADRS total scores. In addition, we used demographic and C-SSRS information to assess suicide risk.
RESULTS: Among 81 MDD subjects, we observed a significant reduction in suicidality and this change was positively correlated with a change in depressive symptoms. A significant difference between active and sham stimulation conditions provided evidence for antidepressant effects. Previous suicide attempts, not being in a relationship, and high levels of anxiety and impulsivity showed a relationship with larger anti-suicidal effects.
CONCLUSIONS: As neither suicide nor other serious adverse events were evidenced in this trial, this seems a safe and viable procedure to reduce suicidality and severity of depressive symptoms. Moreover, we saw more pronounced effects in those with higher risk profiles. Unlike MADRS, composite suicidal scores did not provide evidence of an effect between conditions in this crossover design study. Even so, based on our promising results, larger studies could contribute to improving the characterization of the anti-suicidal placebo effect and validate the applicability of iTBS in depressed, suicidal patients. This article is protected by copyright. All rights reserved.
Language: en |