Ketamine-assisted Psychotherapy for Depression

This trial explores the safety and effectiveness of ketamine-assisted group therapy for Spanish-speaking adults with depression. It investigates whether combining ketamine, an anesthetic, with therapy sessions can improve depression symptoms. The study is open to Latinx adults fluent in Spanish who have been diagnosed with major depressive disorder. Participants must already be seeing a psychiatrist and primary care provider. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to pioneering mental health solutions.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research has shown that ketamine is generally safe and well-tolerated for treating depression. In studies involving patients with treatment-resistant depression, ketamine proved safe. For instance, detailed research indicates that patients handle it well, with no major safety concerns reported.

Another review found that the FDA approved a type of ketamine, called esketamine, for treating severe depression. This approval suggests that ketamine is considered safe for similar conditions.

In everyday use, patients receiving ketamine did not show signs of suicidal behavior or addiction. This suggests that, even outside of strict studies, ketamine is relatively safe.

Researchers are excited about ketamine-assisted psychotherapy for depression because it offers a rapid-acting alternative to traditional antidepressants, which often take weeks to show effects. Unlike most treatments that primarily target serotonin levels, ketamine works differently by acting on the brain's glutamate system, potentially leading to faster relief from depressive symptoms. This unique mechanism may also help individuals who haven't responded well to standard therapies like SSRIs or SNRIs, offering new hope for those struggling with treatment-resistant depression.

Research has shown that ketamine can greatly improve depression symptoms. In one study, 52% of participants experienced a complete disappearance of severe depression symptoms after just three ketamine treatments over 11 days. Another study found clear improvement in depression, anxiety, and overall illness severity after two weeks and one month of treatment. Ketamine has also proven to be at least as effective as electroconvulsive therapy (ECT), with 55% of patients reporting their symptoms were reduced by half or more. These findings suggest ketamine has strong potential to effectively treat depression. Participants in this trial will receive ketamine in an open-label, single-arm study to further evaluate its effectiveness in treating depression.⁶⁷⁸⁹¹⁰