AI Article Synopsis
- Bipolar disorder (BD) is a severe mental illness often characterized by long periods of depression; recent studies have shown that a new treatment called accelerated intermittent theta-burst stimulation (aiTBS) has been effective for treatment-resistant major depressive disorder but hasn't been tested for BD.
- This study aimed to assess the effectiveness of aiTBS for individuals with treatment-resistant BD by conducting a randomized clinical trial with participants who had previously failed multiple antidepressant treatments.
- Results indicated that participants receiving the active aiTBS treatment showed a significant reduction in depression scores compared to those receiving a sham treatment, suggesting that aiTBS may be a promising option for treating difficult-to-man
Article Abstract
Importance: Bipolar disorder (BD) is chronic and disabling, with depression accounting for the majority of time with illness. Recent research demonstrated a transformative advance in the clinical efficacy of transcranial magnetic stimulation for treatment-resistant major depressive disorder (MDD) using an accelerated schedule of intermittent theta-burst stimulation (aiTBS), but the effectiveness of this treatment for treatment-refractory BD is unknown.
Objective: To evaluate the effectiveness of aiTBS for treatment-refractory BD.
Design, Setting, And Participants: This randomized clinical trial, conducted from March 2022 to February 2024, included individuals with treatment-resistant BD with moderate to severe depressive episodes referred from the Penn Bipolar outpatient clinic. Included patients had 2 or more prior failed antidepressant trials by Antidepressant Treatment History Form criteria and no other primary psychiatric diagnosis, were receiving a mood stabilizer for 4 or more weeks, and had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or higher.
Intervention: Prior to treatment, resting-state functional magnetic resonance imaging was used to compute personalized left dorsolateral prefrontal cortex target by connectivity to subgenual anterior cingulate cortex. Patients were randomized 1:1 to 10 sessions per day of imaging-guided active or sham aiTBS for 5 days with 1 session per hour at 90% resting motor threshold for 90 000 pulses total.
Main Outcome And Measures: The main outcome was repeated MADRS scores before and after treatment.
Results: A total of 24 participants (12 [50%] female; 12 [50%] male; mean [SD] age, 43.3 [16.9] years) were randomized to active (n = 12) or sham (n = 12) aiTBS. All participants completed treatment and 1-month follow-up. MADRS scores were significantly lower in the active group (mean [SD], 30.4 [4.8] at baseline; 10.5 [6.7] after treatment) than in the sham group (28.0 [5.4] at baseline; 25.3 [6.7] after treatment) at treatment end (estimated difference, -14.75; 95% CI, -19.73 to -9.77; P < .001; Cohen d, -2.19).
Conclusion And Relevance: In this randomized clinical trial, aiTBS was more effective than sham stimulation for depressive symptom reduction in patients with treatment-resistant BD. Further trials are needed to determine aiTBS durability and to compare with other treatments.
Trial Registration: ClinicalTrials.gov Identifier: NCT05228457.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11238064 | PMC |
| http://dx.doi.org/10.1001/jamapsychiatry.2024.1787 | DOI Listing |
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