NCT05501626

Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder

Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder: Randomized, Controlled, Double-blind, Parallel-group Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. The use of repetitive transcranial magnetic stimulation (rTMS) has been presented as an effective, safe and well-tolerated alternative to the treatment of uni- and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, theta-burst stimulation (TBS), whose studies have shown similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials performed to date evaluate the use of TBS in patients with unipolar depression or mixed samples of uni and bipolar patients. The effectiveness of TBS exclusively in BD has not been properly studied. METHODS: We will perform a 6-week, double-blind, randomized, parallel-group, sham-controlled clinical trial of active or sham TBS. We will recruit 60 patients aged between 18 and 65 years with a diagnosis of BD type I in a current moderate or severe major depressive episode resistant to at least two first- or second-line pharmacological treatments, according to CANMAT guidelines. The primary outcome measure will be the assessment of TBS efficacy through difference in scores on 17-item Hamilton Depression Scale (HAM-D) from baseline until the end of week 6 of intervention between active and sham groups. KEYWORDS: randomized clinical trial; transcranial magnetic stimulation; bipolar affective disorder; major depression.

Conditions

• Bipolar Disorder, Type 1

Interventions

Type	Name	Description
DEVICE	Active Theta Burst Stimulation (TBS)	Each session will be comprised of ACTIVE TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses.
DEVICE	Sham Theta Burst Stimulation (TBS)	Each session will be comprised of SHAM TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses.

Timeline

• Start date: 2022-07-10
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2022-08-15
• Last updated: 2022-08-15

Locations

1 site across 1 country: Brazil