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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Time Spent on Mindset App
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Esketamine
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.
干预措施: Esketamine (Drug)
Esketamine
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.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Esketamine
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.
干预措施: Antidepressant (Drug)
结局指标
主要结局
Time Spent on Mindset App
时间窗: From Week 2 up to Week 13
Time spent on Mindset app will be reported for participants.
SUS Scores (CBT Therapists)
时间窗: 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)
时间窗: 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).
System Usability Scale (SUS) Scores (Participants)
时间窗: 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.
Number of Times Mindset App Used
时间窗: From Week 2 up to Week 13
Number of times the Mindset app is used will be reported.
Clinician Feedback
时间窗: 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.
Exit Survey
时间窗: Week 13
Exit survey is a survey including ratings regarding participant impression of features of the Mindset app.
Pattern of Mindset App Used
时间窗: From Week 2 up to Week 13
Pattern of Mindset app usage will be reported.
CBT Therapist Assessment of Completion of Action Plan
时间窗: 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.
Percentage of Participants Able to Engage in CBT
时间窗: 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.
Timing of CBT Readiness after Dosing
时间窗: 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.
Net Promoter Scale Scores (Participants)
时间窗: 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).
Participant Interviews
时间窗: Week 20
Optional qualitative feedback from study participants (participant's interviews) on the usefulness of the Mindset in conjunction with esketamine will be reported.
Frequency of Use of Clinician Dashboard Used
时间窗: From Week 2 up to Week 13
Frequency of use of clinician dashboard will be reported.
次要结局
- Number of Participants with Abnormalities in Vital Signs(From Week 2 up to Week 13)
- Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale Score(Pre-dose, 40 minutes and 90 minutes post-dose up to Week 4)
- Columbia Suicide Severity Rating (C-SSRS) Score(Up to Week 13)
- 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)
- Clinical Global Assessment of Discharge Readiness (CGADR) Score(From Week 2 up to Week 13)