Clinical TrialMajor Depressive Disorder (MDD)Completed

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.

Target Enrollment
100 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

20 sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Esketamine + CBT

experimental

All participants receive esketamine per FDA label; randomized to CBT (in-person + computer-assisted, Good Days Ahead) consisting of 20 sessions over 16 weeks.

Interventions

  • Compound
    via Other• 20 sessions over 16 weeks

    First 4 weeks twice weekly; thereafter weekly. Esketamine given as part of standard care per FDA label.

Esketamine + TAU

waitlist

All participants receive esketamine per FDA label; randomized to treatment-as-usual (no formal CBT).

Interventions

  • Compound
    via Other• TAU

    Treatment as usual; may include physician visits and non‑CBT psychotherapy. Esketamine given as part of standard care per FDA label.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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: 6 treatments with Esketamine at a dose of 56 mg or more with no clinical response; or 6 treatments of IV ketamine at a dose between 0.4 mg/kg and 0.7 mg/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

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment100 participants
  • Timeline
    Start: 2021-03-05
    End: 2024-08-31
  • Topic
    Major Depressive Disorder (MDD)

Locations

UAB Medicine | Heersink School of Medicine — Birmingham, Alabama, United States
Yale University — New Haven, Connecticut, United States
Emory University — Atlanta, Georgia, United States

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