Medi-TBS for Depression

This trial explores a new treatment for individuals with depression that hasn't improved with other therapies. It combines a special type of brain stimulation, called intermittent Theta Burst Stimulation (iTBS), with digital mindfulness exercises to enhance mood and cognitive skills. Participants will try various mindfulness techniques alongside the brain stimulation to determine the most effective combination. Individuals diagnosed with major depression who haven't found success with at least one antidepressant medication may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to the development of potentially effective therapies.

The trial does not specify if you need to stop taking your current medications. However, you should not have started any new antidepressant therapy or increased your dose in the four weeks before the trial.

Previous studies have shown that intermittent theta burst stimulation (iTBS) is generally safe for treating depression. Research indicates that iTBS, a type of repetitive brain stimulation, is well-tolerated. Most people experience only mild side effects, such as headaches or slight discomfort at the stimulation site. One study found that iTBS effectively reduced depression and anxiety symptoms with minimal side effects. The Medi-TBS study combines this treatment with digital mindfulness training to enhance its effects. Although the trial is still in an early phase and safety data is still being collected, past research on iTBS supports its safety profile.¹²³⁴⁵

Researchers are excited about Medi-TBS for depression because it combines digital mindfulness training with a cutting-edge brain stimulation technique called iTBS. Unlike traditional antidepressants, which often take weeks to show effects, Medi-TBS targets the brain's left dorsolateral prefrontal cortex with precision, potentially offering quicker symptom relief. The Medi1-TBS arm focuses on attention to breathing, while Medi3-TBS emphasizes intermittent deep breathing, adding a personalized approach to treatment. This dual approach could enhance mental well-being by integrating mind and brain therapies, paving the way for more effective depression treatments.

Research has shown that intermittent theta burst stimulation (iTBS) reduces depression symptoms more effectively than a placebo. One study found that depression scores dropped significantly after iTBS sessions, indicating symptom relief. In this trial, participants in the Medi1-TBS arm will receive iTBS combined with digital mindfulness training focused on attention to breathing. Meanwhile, participants in the Medi3-TBS arm will receive iTBS combined with mindfulness training focused on intermittent deep breathing. This combined approach aims to enhance the brain's ability to adapt and grow, potentially offering better results for people with depression that hasn't responded to other treatments.¹²⁶⁷⁸