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

Depression and Suicide Clinical Trial

Official title: CBT-ENDURE: Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Specific Aim 1: To determine the feasibility and safety of performing a larger study examining the effectiveness and mechanism of action of CBT to improve the longer-term outcomes following esketamine treatment in patients hospitalized for suicidal ideation or suicide attempt.

Specific Aim 2: To evaluate the appropriateness and utility of the proposed tests of cognitive control measures in exploring the mechanisms underlying the effects on depression of esketamine and the combination of esketamine+CBT.

Specific Aim 3: To examine the efficacy of esketamine+CBT combination compared to esketamine+TAU in reducing suicidal ideation.

In August 2022, the targeted enrollment was expanded to include outpatient participants, the anticipated enrollment was increased from 60 to 100 participants as a result. ;

Related Conditions & MeSH terms

• Depression
• Depression and Suicide
• Depressive Disorder
• Suicidal Ideation
• Suicide

• NCT number: NCT04760652
• Study type: Interventional
• Source: Yale University
• Contact: Cindy Voghell
• Phone: 203-764-9131
• Email: cynthia.voghell@yale.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2021
• Completion date: August 31, 2024