27th National Clinical Education Symposium Presentation Abstracts

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30 APRIL 2025, WEDNESDAY
13:00-14:00 ORAL PRESENTATION SESSION - 13

Comparison of Bilateral Accelerated Theta Burst and Unilateral Accelerated Theta Burst Stimulation for Treatment-Resistant Depression: A Randomized Sham-Controlled Trial

Hakan Emre Babacan1, Ömer Faruk Uygur1

1. Department of Psychiatry, Ataturk University Faculty of Medicine, Erzurum, Türkiye

DOI: 10.5080/kes27.abs153 Page 13-14

BACKGROUND AND AIM: Treatment-resistant depression (TRD) is a disabling illness that causes significant personal suffering and economic costs. Approximately 44% of patients with depression do not respond to two consecutive antidepressant treatments. Furthermore, TRD is an important clinical challenge due to its association with high suicide risk and loss of functioning. Many methods have been used to assess TRD. Intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) for up to 6 weeks has been approved by the US Food and Drug Administration (FDA) for the treatment of TRD. To reduce the financial and temporal burden of iTBS, accelerated iTBS with higher doses and multiple sessions per day have been developed. aiTBS protocol known as Stanford neuromodulation therapy (SNT) has shown promising results, with a response rate of 64.3% at 4-week follow-up in TRD patients. The SNT involves 10 iTBS sessions per day (1800 pulses per session), delivered to the left DLPFC with 50-minute inter-session intervals over 5 consecutive days. This has been shown to be equivalent to 30 standard iTBS sessions per day. In addition to iTBS, continuous TBS (cTBS) delivered to the right DLPFC has shown therapeutic efficacy in patients with TRD. Due to its inhibitory effect on the cerebral cortex, cTBS is increasingly being investigated to manage anxiety symptoms. It is noteworthy that anxiety shows a moderate covariance with suicide risk. We predicted that both accelerated cTBS (a-cTBS) and a-iTBS may be strong candidates for the treatment of suicidal ideation and depression in individuals with TRD. In our study, we compared the clinical efficacy of accelerated left DLPFC iTBS and right DLPFC cTBS versus left DLPFC iTBS and right DLPFC pseudo-cTBS in TRD patients with moderate to severe suicidal ideation. Both of these protocols were administered for 10 consecutive working days. It was hypothesized that both protocols would reduce symptoms of depression, but bilateral administration would potentially be more effective than in the sham control group. This study also represents the first comparison of bilateral and unilateral practice.
METHODS: We conducted a double-blind randomized controlled trial using a 1:1 ratio in a parallel design. The study was prospectively registered in the US Clinical Trials Registry. All procedures were performed in accordance with the ethical standards stated in the Declaration of Helsinki. Our study was approved by the Turkish Medicines and Devices Agency with the registration number 24-AKD-135. All participants gave written informed consent before participating in any study procedures. Participants; Between 18 and 65 years of age, diagnosed with Major Depressive Disorder (MDD) according to DSM 5, with a severity of illness of 7 points or more according to the Maudsley staging method, unresponsive to 2 different antidepressant, Patients with Hamilton Depression Rating Scale-17 [HDRS-17] and Montgomery Asberg Depression Rating Scale [MADRS] scores of 20 or higher, right hand dominance, and who had used the same antidepressant at the same dose for the last 4 weeks were selected. In our study, left and right dorsolateral prefrontal cortex (DLPFC) were targeted using scalp measurements. A group of 20 patients (group A) received a total of 50 sessions, 5 sessions per day, 5 days a week for 2 weeks. At least 30 minutes rest time was given between each session. One session in group A consisted of a high-frequency (5 Hz) intermittent theta burst (iTBS) protocol with 1800 pulses to the left DLPFC at 90% motor threshold, followed by a continuous theta burst (cTBS) protocol with 600 pulses at 5 Hz to the right DLPFC at 80% motor threshold. The other patient group (Group B) consisting of 20 people received a total of 50 sessions, 5 sessions per day, 5 days a week for 2 weeks. A minimum of 30 minutes of rest was given between each session. One session applied to Group B included first a application of high-frequency (5 Hz) intermittent theta burst (iTBS) containing 1800 pulses at 90% motor threshold to the left DLPFC, followed by a sham application of continuous theta burst (cTBS) containing 600 pulses at 5 Hz frequency to the right DLPFC at 80% motor threshold. Response to treatment was defined as ≥50% decrease in MADRS score and remission as MADRS score ≤10; HDRS-17 score was defined as ≥50% decrease in HDRS-17 score and remission as HDRS-17 score ≤7.
RESULTS: There were no significant differences in age, gender, body mass index, years of education, age at onset of depression, last depressive episode, history of suicide attempt, number of suicide attempts, MSM, depression and anxiety scores and functioning score. No serious side effects (epileptic seizures, suicide attempts, etc.) were observed in patients in both groups during treatment and follow-up.
CONCLUSIONS: Bilateral application did not have a significant difference in terms of depression, anxiety, suicidal thoughts and functionality compared to unilateral application; The fact that cTBS did not provide additional contribution in terms of suicidal and anxiety scores was the most important different result that we found in contrast to the recent study. It was found that bilateral application did not make a significant difference in terms of depression, anxiety, suicidal thoughts and functionality compared to unilateral application; both bilateral and unilateral application were found to be tolerable and safe. The fact that cTBS was administered in 600 pulses, no sham coil was used, and errors in the detection of the right DLPFC region may have led to this result. There is a need for randomized sham-controlled studies with larger samples, longer follow-ups and increased number of cTBS pulses. REFERENCES Eleanor J Cole, Katy H Stimpson, Brandon S Bentzley et al. (2020) Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry 177: 716-26. Zhao H, Jiang C, Zhao M et al. (2024) Comparisons of Accelerated Continuous and Intermittent Theta Burst Stimulation for Treatment-Resistant Depression and Suicidal Ideation. Biol. Psychiatry 96:26-33 Keywords: Treatment-Resistant Depression, Accelarated Transcranial Magnetic Stimulation, Theta Burst Stimulation, Response, Remission