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CompletedNot applicable

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

NCT04760652 · ENDURE · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
92
Target enrolment
3
Study sites
3 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • To determine the feasibility of performing a larger study with similar design by measuring of recruitment rates.

    Measured over Recruitment rates will be assessed at 18 months.

  • To determine the feasibility of performing a larger study with similar design by measuring attrition.

    Measured over Attrition will be assessed at 18 months.

  • Reasons for discontinuation

    Measured over Discontinuation will be assessed at 18 months.

  • To determine the safety of performing a larger study with similar design.

    Measured over Safety will be assessed at 18 months.

  • Evaluate the appropriateness of the proposed tests of cognitive control measures in exploring the mechanisms of change.

    Measured over The appropriateness will be assessed at the end of study (18 months).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participants are eligible for the study if they meet all the following criteria: 1. Written informed consent before any study procedures are performed 2. Meeting criteria for inpatient admission for suicidal ideation or attempt at one of the study sites 3. Recommended by a physician for esketamine treatment 4. Males or females ages 18 through 65 years of age 5. Diagnosis of major depressive disorder as confirmed by the MINI (inpatient) or the HAM-D-17 (outpatient) 6. Willing to adhere to a reliable form of contraception throughout the trial and for one month following completion of the trial (for subjects who are sexually active) 7. 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 Exclusion Criteria: * Participants are excluded if they meet any of the following criteria: 1. Active substance use disorder (except tobacco) within 6 months of screening date 2. Meets DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or pervasive development disorder 3. Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to meaningfully engage in CBT (per investigator judgment) 4. Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. 5. Current or planned participation in a formal CBT program defined by the following characteristics, each session has an agenda, a homework assignment is given at each session, and the homework assignment from the previous session is reviewed at the following appointment. 6. Previous Esketamine or ketamine treatment that did not produce a clinical response as outlined below. * 6 treatments with Esketamine at a dose of 56 mg or more with no clinical response * 6 treatments of IV ketamine at a dose between 0.4 mg/kg and 0.7mg /kg with no clinical response Patients must not have received Esketamine or ketamine treatment within the past 12 weeks of time of enrollment. 7. The patient is pregnant or breastfeeding 8. Unable to give informed consent 9. Was previously enrolled/randomized into the trial 10. Patients who have a contraindication to receiving Esketamine including any of the following: * aneurysmal vascular disease * arteriovenous malformation * history of intracerebral hemorrhage * hypersensitivity to esketamine or ketamine

Where

3 study sites

FacilityCityRegionCountry
UAB Medicine | Heersink School of MedicineBirminghamAlabamaUnited States
Yale UniversityNew HavenConnecticutUnited States
Emory UniversityAtlantaGeorgiaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04760652 on ClinicalTrials.gov →

Last updated in the registry 2025-07-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits