Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention (ENDURE)
Rater-blinded, randomised controlled trial (n=100) in patients with major depression and suicidal ideation; all receive esketamine and are randomised 1:1 to computer-assisted/in-person CBT (20 sessions over 16 weeks) versus treatment-as-usual to assess feasibility, safety, and efficacy for relapse prevention.
Details
This rater-blinded randomized trial enrolls adults hospitalised for suicidal ideation or attempt who are recommended for esketamine; all participants receive esketamine per FDA label and are randomised to receive CBT (Good Days Ahead; 20 sessions over 16 weeks) or treatment-as-usual.
Primary aims are to assess feasibility and safety for a larger trial, explore cognitive-control mechanisms of esketamine and esketamine+CBT, and evaluate efficacy of esketamine+CBT versus esketamine+TAU in reducing suicidal ideation; enrollment was expanded to 100 (incl. outpatients) in August 2022.