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
Primary Purpose
Depression
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Esketamine
Cognitive Behavioral Therapy (CBT)
Antidepressant
Sponsored by
About this trial
This is an interventional other trial for Depression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Yale University
- Rush University Medical Center
- University of Chicago
- Sheppard Pratt Health System
- University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esketamine
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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).
Exit Survey
Exit survey is a survey including ratings regarding participant impression of features of the Mindset app.
Time Spent on Mindset App
Time spent on Mindset app will be reported for participants.
Number of Times Mindset App Used
Number of times the Mindset app is used will be reported.
Pattern of Mindset App Used
Pattern of Mindset app usage will be reported.
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.
Participant Interviews
Optional qualitative feedback from study participants (participant's interviews) on the usefulness of the Mindset in conjunction with esketamine will be reported.
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.
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).
Frequency of Use of Clinician Dashboard Used
Frequency of use of clinician dashboard will be reported.
Clinician Feedback
Qualitative feedback on clinician dashboard and participant use of the mindset app in conjunction with esketamine (clinician feedback) will be reported.
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.
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.
Secondary Outcome Measures
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).
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
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
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.
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.
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)?"
Full Information
NCT ID
NCT05268497
First Posted
February 25, 2022
Last Updated
September 21, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05268497
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
due to budget decision and wanting to pursue other research priorities
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 7, 2023 (Anticipated)
Study Completion Date
June 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esketamine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
SPRAVATO, JNJ-54135419, Non-Investigational Medicinal Product/Auxiliary Medicinal Product (NIMP/AxMP)
Intervention Description
Esketamine will be self-administered as nasal spray.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
Clinician-directed CBT supplemented by the Mindset app will be administered.
Intervention Type
Drug
Intervention Name(s)
Antidepressant
Intervention Description
Antidepressant will be administered orally.
Primary Outcome Measure Information:
Title
System Usability Scale (SUS) Scores (Participants)
Description
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.
Time Frame
Week 13
Title
Net Promoter Scale Scores (Participants)
Description
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).
Time Frame
Week 13
Title
Exit Survey
Description
Exit survey is a survey including ratings regarding participant impression of features of the Mindset app.
Time Frame
Week 13
Title
Time Spent on Mindset App
Description
Time spent on Mindset app will be reported for participants.
Time Frame
From Week 2 up to Week 13
Title
Number of Times Mindset App Used
Description
Number of times the Mindset app is used will be reported.
Time Frame
From Week 2 up to Week 13
Title
Pattern of Mindset App Used
Description
Pattern of Mindset app usage will be reported.
Time Frame
From Week 2 up to Week 13
Title
CBT Therapist Assessment of Completion of Action Plan
Description
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.
Time Frame
From Week 2 up to Week 13
Title
Participant Interviews
Description
Optional qualitative feedback from study participants (participant's interviews) on the usefulness of the Mindset in conjunction with esketamine will be reported.
Time Frame
Week 20
Title
SUS Scores (CBT Therapists)
Description
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.
Time Frame
Up to 14 months (at the end of study)
Title
Net Promoter Scale Scores (CBT Therapists)
Description
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).
Time Frame
Up to 14 months (at the end of study)
Title
Frequency of Use of Clinician Dashboard Used
Description
Frequency of use of clinician dashboard will be reported.
Time Frame
From Week 2 up to Week 13
Title
Clinician Feedback
Description
Qualitative feedback on clinician dashboard and participant use of the mindset app in conjunction with esketamine (clinician feedback) will be reported.
Time Frame
Up to 14 months
Title
Percentage of Participants Able to Engage in CBT
Description
Percentage of participants able to engage in CBT on the day of dosing for each week of the study and overall will be reported.
Time Frame
From Week 2 up to Week 13
Title
Timing of CBT Readiness after Dosing
Description
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.
Time Frame
From Week 2 up to Week 13
Secondary Outcome Measure Information:
Title
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale Score
Description
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).
Time Frame
Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4
Title
Clinician Administered Dissociative States Scale (CADSS) Score
Description
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
Time Frame
Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
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
Time Frame
From Week 2 up to Week 13
Title
Number of Participants with Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs (pulse/heart rate, blood pressure, and body temperature) will be reported.
Time Frame
From Week 2 up to Week 13
Title
Columbia Suicide Severity Rating (C-SSRS) Score
Description
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.
Time Frame
Up to Week 13
Title
Clinical Global Assessment of Discharge Readiness (CGADR) Score
Description
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)?"
Time Frame
From Week 2 up to Week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
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
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