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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

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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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.

Mentions: At time-point 4 (T4), i.e., 1 month after baseline and 2 weeks after finalization of the treatment protocol, 18 of the 46 therapy-resistant depressed patients showed a depression-response, as defined by a decrease of at least 50% of their HDRS scores. This means that 39% of these therapy-resistant depressed patients responded to the stimulation protocol regarding their depressive symptoms (mean HDRS T1 = 21.50 (SD = 5.57); mean HDRS T4 = 12.83 (SD = 7.33)). Within the suicidal subgroup, 13 out of 42 patients showed a decrease of at least 50% of the HDRS scores at time-point T4, which equals 31%. When we divided this subgroup into HDRS-responders and HDRS-non-responders to evaluate the effect on suicide risk, the mixed linear regression model showed a significant decrease in BSI score in both groups, lasting up to T4 with a significant effect of Time (p < 0.01) but no significant effect of the factor “HDRS-response on T4” (p = 0.378) and no significant interaction effect (p = 0.19; see Figure 3). An independent-samples-t-test showed no significant difference in BSI score at baseline between the group of HDRS-responders and HDRS-non-responders (t(30) = 0.42, p = 0.68). Applying a similar regression model replacing the dichotomous variable with the continuous changes in HDRS scores showed similar results: no significant interaction was found between time and HDRS change (p = 0.20).


Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial
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.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5037167&req=5

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.
Mentions: At time-point 4 (T4), i.e., 1 month after baseline and 2 weeks after finalization of the treatment protocol, 18 of the 46 therapy-resistant depressed patients showed a depression-response, as defined by a decrease of at least 50% of their HDRS scores. This means that 39% of these therapy-resistant depressed patients responded to the stimulation protocol regarding their depressive symptoms (mean HDRS T1 = 21.50 (SD = 5.57); mean HDRS T4 = 12.83 (SD = 7.33)). Within the suicidal subgroup, 13 out of 42 patients showed a decrease of at least 50% of the HDRS scores at time-point T4, which equals 31%. When we divided this subgroup into HDRS-responders and HDRS-non-responders to evaluate the effect on suicide risk, the mixed linear regression model showed a significant decrease in BSI score in both groups, lasting up to T4 with a significant effect of Time (p < 0.01) but no significant effect of the factor “HDRS-response on T4” (p = 0.378) and no significant interaction effect (p = 0.19; see Figure 3). An independent-samples-t-test showed no significant difference in BSI score at baseline between the group of HDRS-responders and HDRS-non-responders (t(30) = 0.42, p = 0.68). Applying a similar regression model replacing the dichotomous variable with the continuous changes in HDRS scores showed similar results: no significant interaction was found between time and HDRS change (p = 0.20).

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