Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention (ENDURE)

This double-blind, randomized controlled trial (n=100) conducted by Yale University aims to assess the feasibility, safety, and efficacy of Cognitive Behavioral Therapy (CBT) following esketamine treatment for Major Depression with Suicidal Ideation (MDSI; MDD + SI).

All participants will receive esketamine, and they will be randomized (1:1) to receive either CBT or Treatment As Usual (TAU) following esketamine administration.

The study has several specific aims, including evaluating the effectiveness of CBT in improving longer-term outcomes, exploring the mechanisms underlying the effects of esketamine and esketamine+CBT combination on depression, and comparing the efficacy of esketamine+CBT combination to esketamine+TAU in reducing suicidal ideation.

Participants eligible for the study include those admitted for suicidal ideation or attempt, recommended for esketamine treatment, aged 18 to 65, and diagnosed with major depressive disorder. Exclusion criteria include active substance use disorder (except tobacco), certain psychiatric disorders, previous non-responsive esketamine or ketamine treatment, pregnancy, and contraindications to receiving esketamine.

The study design is an interventional, randomized trial with parallel assignment, and it is designed to assess treatment outcomes, feasibility, and safety measures. Recruitment began in March 2021, and the estimated study completion date is August 2024.

Topic Depression Suicidality
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 05 March 2021
End date 31 August 2024
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 18- 65
Therapy Yes

Trial Details

This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine.

NCT Number NCT04760652

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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