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DepressionPhase 1NCT05268497

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

A Phase 1 study testing Esketamine, Cognitive Behavioral Therapy (CBT) and Antidepressant in people with Depression, run by Janssen Research & Development, LLC at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
Esketamine, Cognitive Behavioral Therapy (CBT) and Antidepressant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
1 Sep 2022to 7 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

    Cincinnati, Ohio, 45219

  • Yale University

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Assessment of Feasibility of Using Clinician-Directed Cognitive Behavior Therapy Supplemented by a Digital Application in Conjunction With Esketamine (SPRAVATO®) in Participants With Treatment-Resistant Depression

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
Being tested
Esketamine, Cognitive Behavioral Therapy (CBT), Antidepressant
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsketamineDrug

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

    Esketamine will be self-administered as nasal spray.

  • Cognitive Behavioral Therapy (CBT)Behavioural

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

  • AntidepressantDrug

    Antidepressant will be administered orally.

Study groups in NCT05268497
Study groupRoleWhat they receive
EsketamineExperimentalParticipants 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.
Receives: Drug: Esketamine; Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Antidepressant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 13

  2. 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).

    Measured: Week 13

  3. Exit Survey

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

    Measured: Week 13

  4. Time Spent on Mindset App

    Time spent on Mindset app will be reported for participants.

    Measured: From Week 2 up to Week 13

  5. Number of Times Mindset App Used

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

    Measured: From Week 2 up to Week 13

  6. Pattern of Mindset App Used

    Pattern of Mindset app usage will be reported.

    Measured: From Week 2 up to Week 13

  7. 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.

    Measured: From Week 2 up to Week 13

  8. Participant Interviews

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

    Measured: Week 20

  9. 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.

    Measured: Up to 14 months (at the end of study)

  10. 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).

    Measured: Up to 14 months (at the end of study)

  11. Frequency of Use of Clinician Dashboard Used

    Frequency of use of clinician dashboard will be reported.

    Measured: From Week 2 up to Week 13

  12. Clinician Feedback

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

    Measured: Up to 14 months

  13. 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.

    Measured: From Week 2 up to Week 13

  14. 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.

    Measured: From Week 2 up to Week 13

Secondary outcomes (6)

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

    The MOAA/S will be used to measure treatment-emergent sedation with correlation to levels of sedation defined by the American Society of Anesthesiologists (ASA) continuum. The MOAA/S scores range from 0=no response to painful stimulus (corresponds to ASA continuum for general anesthesia) to 5=readily responds to name spoken in normal tone (awake; corresponds to ASA continuum for minimal sedation).

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

  2. Clinician Administered Dissociative States Scale (CADSS) Score

    The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. The CADSS consists of 23 subjective items, divided into 3 components: depersonalization (Items 3 to 7, 20, and 23), derealization (Items 1, 2, 8 to 13, 16 to 19, and 21) and amnesia (Items 14, 15, and 22). Participant's responses are coded on a 5-point scale (0=not at all through to 4=extremely). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition

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

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

    Number of participants with TEAEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment

    Measured: From Week 2 up to Week 13

  4. Number of Participants with Abnormalities in Vital Signs

    Number of participants with abnormalities in vital signs (pulse/heart rate, blood pressure, and body temperature) will be reported.

    Measured: From Week 2 up to Week 13

  5. Columbia Suicide Severity Rating (C-SSRS) Score

    C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.

    Measured: Up to Week 13

  6. Clinical Global Assessment of Discharge Readiness (CGADR) Score

    The CGADR will be used to measure the participant's current clinical status and is the clinician's assessment of the readiness to be discharged from the study site. The clinician will answer "Yes" or "No" to the question "Is the participant considered ready to be discharged based on their overall clinical status (example, sedation, blood pressure, and other adverse events)?"

    Measured: From Week 2 up to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion7 Jun 2023 (estimated)
  4. Study completion7 Jun 2023 (estimated)

Why it stopped: due to budget decision and wanting to pursue other research priorities

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268497
Sponsor's protocol ID
CR109113
Other IDs
NATRD1001
Status last verified
Apr 2025
First submitted
25 Feb 2022
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Esketamine, Cognitive Behavioral Therapy (CBT) and Antidepressant in people with Depression, run by Janssen Research & Development, LLC at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) Scores (Participants) (time frame: Week 13). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05268497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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