This open-label trial (n=0; withdrawn) was designed to investigate the viability of ketamine-assisted psychotherapy in treating emotional distress related to cancer.
Conducted by Northwell Health, the study aimed to determine if three sessions of Ketamine Assisted Psychotherapy (KAP) during palliative radiation therapy are safe, feasible, and effective in reducing psychological distress.
Patients with moderate-severe cancer-related anxiety or depression undergoing palliative radiation therapy were eligible. Each KAP session, lasting approximately 3 hours, involved the administration of an individualized dose of Ketalar intramuscularly, followed by discussions with a trained psychotherapist. Integration sessions were scheduled the day after each KAP session and one month after the final session.
The primary outcome measure was the percentage of patients completing at least one KAP session, with secondary measures including depression, anxiety, and existential distress levels. The study, with the ClinicalTrials.gov ID NCT05344625, was anticipated to start in October 2023 and conclude by March 15, 2024. However, as of January 24, 2024, the study has been withdrawn by the research team, and no participants have been enrolled.
Trial Details
The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress.NCT Number NCT05344625
Sponsors & Collaborators
Northwell HealthThis company doesn't have a full profile yet, it is linked to a clinical trial.