A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression

NCT05268497 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: CR109113NATRD1001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.

Conditions

Depression

Outcome Measures

Primary Outcomes (14)

• System Usability Scale (SUS) Scores (Participants)

  The SUS provides a reliable tool for measuring the usability of a wide variety of products and services, including hardware, software, mobile devices, websites, and applications. It consists of a 10-item questionnaire with five response options for respondents; from strongly agree to strongly disagree.

  Week 13

• Net Promoter Scale Scores (Participants)

  Net promoter score is a market research measure that asks respondents to rate the likelihood that they would recommend a company, product, or a service to a friend or colleague. Responses are on a rating on a scale of 0 (not at all likely) to 10 (extremely likely).

  Week 13

• Exit Survey

  Exit survey is a survey including ratings regarding participant impression of features of the Mindset app.

  Week 13

• Time Spent on Mindset App

  Time spent on Mindset app will be reported for participants.

  From Week 2 up to Week 13

• Number of Times Mindset App Used

  Number of times the Mindset app is used will be reported.

  From Week 2 up to Week 13

• Pattern of Mindset App Used

  Pattern of Mindset app usage will be reported.

  From Week 2 up to Week 13

• CBT Therapist Assessment of Completion of Action Plan

  Assessment of completion of action plan will be done by CBT therapists through rating on a 5-point likert scale of the participant's progress.

  From Week 2 up to Week 13

• Participant Interviews

  Optional qualitative feedback from study participants (participant's interviews) on the usefulness of the Mindset in conjunction with esketamine will be reported.

  Week 20

• SUS Scores (CBT Therapists)

  The SUS provides a reliable tool for measuring the usability of a wide variety of products and services, including hardware, software, mobile devices, websites, and applications. It consists of a 10-item questionnaire with five response options for respondents; from strongly agree to strongly disagree.

  Up to 14 months (at the end of study)

• Net Promoter Scale Scores (CBT Therapists)

  Net promoter score is a market research measure that asks respondents to rate the likelihood that they would recommend a company, product, or a service to a friend or colleague. Responses are on a rating on a scale of 0 (not at all likely) to 10 (extremely likely).

  Up to 14 months (at the end of study)

• Frequency of Use of Clinician Dashboard Used

  Frequency of use of clinician dashboard will be reported.

  From Week 2 up to Week 13

• Clinician Feedback

  Qualitative feedback on clinician dashboard and participant use of the mindset app in conjunction with esketamine (clinician feedback) will be reported.

  Up to 14 months

• Percentage of Participants Able to Engage in CBT

  Percentage of participants able to engage in CBT on the day of dosing for each week of the study and overall will be reported.

  From Week 2 up to Week 13

• Timing of CBT Readiness after Dosing

  Timing of CBT readiness after dosing will be reported. Determination of readiness will be based on clinician judgement of CBT readiness to engage in CBT based on alertness and ability to concentrate after dosing.

  From Week 2 up to Week 13

Secondary Outcomes (6)

• Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale Score

  Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4

• Clinician Administered Dissociative States Scale (CADSS) Score

  Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  From Week 2 up to Week 13

• Number of Participants with Abnormalities in Vital Signs

  From Week 2 up to Week 13

• Columbia Suicide Severity Rating (C-SSRS) Score

  Up to Week 13

Study Arms (1)

Esketamine

EXPERIMENTAL

Participants will receive esketamine nasal spray (Dose 1 or Dose 2) twice weekly for 4 weeks (Induction Phase), followed by once a week dose (Dose 1 or Dose 2) for 8 weeks (Maintenance Phase), in conjunction with an oral antidepressant. Clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app will be administered by a clinician following esketamine dosing once the participants is considered ready to engage in therapy, based on the clinician judgement of CBT readiness.

Drug: Esketamine; Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Antidepressant

Interventions

Esketamine DRUG

Esketamine will be self-administered as nasal spray.

Also known as: SPRAVATO, JNJ-54135419, Non-Investigational Medicinal Product/Auxiliary Medicinal Product (NIMP/AxMP)

Esketamine

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Clinician-directed CBT supplemented by the Mindset app will be administered.

Esketamine

Antidepressant DRUG

Antidepressant will be administered orally.

Esketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based upon clinical assessment confirmed by the Mini International Neuropsychiatric Interview (MINI)
• Participant must have had nonresponse to greater than or equal to (\>=) 2 different oral antidepressant treatments of adequate dose and duration in the current episode of depression
• Participant must be currently taking an oral antidepressant.
• Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided

You may not qualify if:

• Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT
• Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
• Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug
• Participant has known allergies, hypersensitivity, intolerance, or contraindications to esketamine/ketamine and/or its excipients

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Yale University

New Haven, Connecticut, 06511, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Esketamine; Cognitive Behavioral Therapy; Antidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: September 1, 2022
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)