Clinical TrialTreatment-Resistant Depression (TRD)EsketamineWithdrawn

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

Single-group feasibility study (n=0, withdrawn) assessing esketamine nasal spray with clinician-directed CBT supported by the Mindset app plus oral antidepressant in participants with treatment-resistant depression.

Target Enrollment
Not specified
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This single-group Phase I feasibility study evaluated esketamine nasal spray administered twice weekly for 4 weeks (induction) then weekly for 8 weeks (maintenance) alongside an oral antidepressant, with clinician-directed CBT supplemented by the Mindset app delivered after dosing when participants were judged ready.

Primary aim was feasibility of combining pharmacological treatment and digital-supported psychotherapy in treatment-resistant depression; safety and tolerability assessed per standard clinical measures.

Study Protocol

Preparation

sessions

Dosing

16 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Esketamine + CBT

experimental

Esketamine nasal spray administered alongside oral antidepressant; clinician-directed CBT supplemented with the Mindset app delivered post-dosing when participant is ready.

Interventions

  • Esketamine
    via Other• twice weekly (4-week induction) then weekly (8-week maintenance)• 16 doses total

    Intranasal spray (Dose 1 or Dose 2 unspecified); administered with concomitant oral antidepressant.

  • Compound
    via Other• per protocol

    Clinician-directed CBT supplemented with the Mindset app, delivered following dosing when clinician judges participant ready to engage.

  • Compound
    via Oral• ongoing

    Concomitant oral antidepressant (standard of care)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

Yale University — New Haven, Connecticut, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Sheppard Pratt Health System — Baltimore, Maryland, United States
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience — Cincinnati, Ohio, United States

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