Clinical trial NCT05268497: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Depression
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: System Usability Scale (SUS) Scores (Participants)
timeFrame: Week 13
measure: Net Promoter Scale Scores (Participants)
timeFrame: Week 13
measure: Exit Survey
timeFrame: Week 13
measure: Time Spent on Mindset App
timeFrame: From Week 2 up to Week 13
measure: Number of Times Mindset App Used
timeFrame: From Week 2 up to Week 13
measure: Pattern of Mindset App Used
timeFrame: From Week 2 up to Week 13
measure: CBT Therapist Assessment of Completion of Action Plan
timeFrame: From Week 2 up to Week 13
measure: Participant Interviews
timeFrame: Week 20
measure: SUS Scores (CBT Therapists)
timeFrame: Up to 14 months (at the end of study)
measure: Net Promoter Scale Scores (CBT Therapists)
timeFrame: Up to 14 months (at the end of study)
measure: Frequency of Use of Clinician Dashboard Used
timeFrame: From Week 2 up to Week 13
measure: Clinician Feedback
timeFrame: Up to 14 months
measure: Percentage of Participants Able to Engage in CBT
timeFrame: From Week 2 up to Week 13
measure: Timing of CBT Readiness after Dosing
timeFrame: From Week 2 up to Week 13
Secondary outcomes:
measure: Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale Score
timeFrame: Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4
measure: Clinician Administered Dissociative States Scale (CADSS) Score
timeFrame: Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Week 2 up to Week 13
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: From Week 2 up to Week 13
measure: Columbia Suicide Severity Rating (C-SSRS) Score
timeFrame: Up to Week 13
measure: Clinical Global Assessment of Discharge Readiness (CGADR) Score
timeFrame: From Week 2 up to Week 13
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: Cincinnati
country: United States
facility: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
state: Ohio
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: