Cognitive Behavioral Therapy After Esketamine for Depression with Suicidal Ideation
(ENDURE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySamuel T Wilkinson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Yale University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults aged 18-65 with major depression and suicidal thoughts, who are recommended for esketamine treatment, can join. They must be willing to use contraception and follow the trial procedures. Excluded are those pregnant or breastfeeding, with certain cognitive disorders, no response to prior ketamine treatments, substance abuse issues within the last 6 months, or other serious medical/psychiatric conditions.

Inclusion Criteria

Written informed consent before any study procedures are performed

In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study

Recommended by a physician for esketamine treatment

+4 more

Exclusion Criteria

I have tried Esketamine or ketamine before, and it didn't work for me.

I am unable to understand and agree to the study's details on my own.

You have been actively using drugs (except for tobacco) within the past 6 months.

+10 more

Participant Groups

The study tests if Cognitive Behavioral Therapy (CBT) after esketamine treatment helps prevent relapse in major depression with suicidal ideation. Participants will either receive computer-assisted CBT or Treatment As Usual (TAU) randomly after their initial esketamine therapy.

2Treatment groups

Experimental Treatment

Active Control

Group I: TAU Treatment As UsualExperimental Treatment1 Intervention

Participants will undergo Treatment as usual (TAU). These patients will undergo standard, post-hospitalization clinical treatments, which many include physician visits and psychotherapy (except for formal CBT).

Group II: CBT Cognitive Behavioral TherapyActive Control1 Intervention

Participants will receive CBT, which will consist of in-person and computer-based component (based on Good Days Ahead). This will consist of 20 sessions given over 16 weeks.