Depression
Conditions
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.
Interventions
DRUGEsketamine
Esketamine will be self-administered as nasal spray.
BEHAVIORALCognitive Behavioral Therapy (CBT)
Clinician-directed CBT supplemented by the Mindset app will be administered.
DRUGAntidepressant
Antidepressant will be administered orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timing of CBT Readiness after Dosing | From Week 2 up to Week 13 | 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. |
| Participant Interviews | Week 20 | 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) | Up to 14 months (at the end of study) | 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) | Up to 14 months (at the end of study) | 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 | From Week 2 up to Week 13 | Frequency of use of clinician dashboard will be reported. |
| Clinician Feedback | Up to 14 months | 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 | From Week 2 up to Week 13 | Percentage of participants able to engage in CBT on the day of dosing for each week of the study and overall will be reported. |
| System Usability Scale (SUS) Scores (Participants) | Week 13 | 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) | Week 13 | 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 | Week 13 | Exit survey is a survey including ratings regarding participant impression of features of the Mindset app. |
| Time Spent on Mindset App | From Week 2 up to Week 13 | Time spent on Mindset app will be reported for participants. |
| Number of Times Mindset App Used | From Week 2 up to Week 13 | Number of times the Mindset app is used will be reported. |
| Pattern of Mindset App Used | From Week 2 up to Week 13 | Pattern of Mindset app usage will be reported. |
| CBT Therapist Assessment of Completion of Action Plan | From Week 2 up to Week 13 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered Dissociative States Scale (CADSS) Score | Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4 | 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) | From Week 2 up to Week 13 | 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 | From Week 2 up to Week 13 | 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 | Up to Week 13 | 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 | From Week 2 up to Week 13 | 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)? |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale Score | Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4 | 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). |
Countries
United States
Outcome results
None listed