TMS + Ketamine for Depression

(BioSelect Trial)

This trial examines two alternative treatments for individuals whose depression hasn't improved with standard methods like medications or talk therapy. Researchers are testing repetitive transcranial magnetic stimulation (rTMS), which uses magnets to stimulate the brain, and ketamine, a fast-acting medication, to determine which works better for different individuals. The goal is to discover if brain scans and other information can help predict who will respond best to each treatment. This study might suit someone with moderate to severe depression who hasn't found relief with at least one standard treatment and isn't currently taking antidepressants or is stable on them. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.

You don't have to stop taking your current medications if they are compatible with the trial and you have been on a stable dose for at least one month before screening. You should plan to stay on this stable dose during the study.

Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) is well-tolerated by patients with depression. Research indicates no serious side effects related to rTMS, and only about 3% of people discontinue the treatment early. This suggests that most individuals can undergo this treatment without major issues. One study found that even a faster, higher-dose version of rTMS was also well-tolerated.

For ketamine, studies have reported its effectiveness and safety in treating depression. When administered intravenously, ketamine was closely monitored for blood oxygen, pulse, and blood pressure to ensure safety during and after treatment. It demonstrated a good safety record in clinics and, in some cases, at home with minimal monitoring.

Researchers are excited about using ketamine and repetitive transcranial magnetic stimulation (rTMS) for depression because they offer unique mechanisms compared to traditional antidepressants like SSRIs or SNRIs. Ketamine acts rapidly, often providing relief within hours by targeting the NMDA receptors in the brain, which is a different pathway than most antidepressants. On the other hand, rTMS uses magnetic fields to stimulate nerve cells, which can enhance brain activity and improve mood without the need for medication. Together, these treatments have the potential to offer faster and more effective relief for individuals with depression, especially those who haven't responded to conventional therapies.

This trial will compare the effectiveness of two treatments for depression: repetitive transcranial magnetic stimulation (rTMS) and ketamine. Studies have shown that rTMS is about twice as effective as a placebo in reducing depression symptoms, with approximately 61% of patients responding well and experiencing significant symptom relief. Ketamine, known for its rapid effects, often reduces depressive symptoms within 24 hours. Research indicates that ketamine can quickly alleviate suicidal thoughts, which is crucial for individuals with severe depression. Both treatments have demonstrated effectiveness, offering hope for those whose depression hasn't improved with standard therapies.⁶⁷⁸⁹¹⁰