Clinical TrialDepressive DisordersEnrolling by invitation

Cognitive Training as an Adjunct to Ketamine in Real-world Clinics

This interventional trial (n=600) will evaluate whether cognitive training can enhance or extend the rapid antidepressant effects of ketamine in patients already receiving ketamine treatment as part of their clinical care.

Target Enrollment
600 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, parallel-group trial will enrol approximately 600 patients already clinically receiving IV ketamine to test whether adjunctive web-based cognitive training versus sham training can enhance or prolong antidepressant response.

Cognitive training consists of self-administered 15–20 minute sessions via a web app delivered during the induction and post-induction phases; primary outcomes include change in depressive symptoms (MADRS) and durability of response.

Study Protocol

Preparation

sessions

Dosing

sessions
20 min each

Integration

sessions

Therapeutic Protocol

other

Study Arms & Interventions

Cognitive Training

experimental

Web-based cognitive training adjunct to clinical ketamine

Interventions

  • Compound
    via Other• multiple sessions

    Sessions of cognitive training exercises (15–20 min) self-administered via a web app

Sham Training

inactive

Web-based sham training

Interventions

  • Compound
    via Other• multiple sessions

    Sessions of sham training exercises (15–20 min) self-administered via a web app

Participants

Ages
18 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. be between the ages of 18 and 80 years
  • 2. score ≥20 on the Montgomery-Asberg Depression Rating Scale (MADRS)
  • 3. per SCID-5-RV interview, meet DSM-5 diagnostic criteria for at least one of the following: Major Depressive Disorder, Bipolar Disorder (I or II), Persistent Depressive Disorder, or Other Specified Depressive or Bipolar Disorder
  • 4. exhibit treatment resistance, defined as: (a) failure to respond to ≥1 adequate trials of an evidence-based treatment for mood disorder [per the Antidepressant Treatment History Form-Short Form Modified Score Sheet (ATHF-SF-Modified)] and/or (b) failure to respond to ≥1 adequate mood stabilizer or other evidence-based treatment trials (for bipolar depression patients) and/or (c) a history of intolerance during attempted trials of evidence-based treatments for mood disorders and/or (d) failure to respond to ≥1 prior treatment trials (e.g., medication, psychotherapy) for Post Traumatic Stress Disorder (PTSD)
  • 5. be eligible and clinically enrolled for upcoming IV ketamine at one of our study clinics according to that clinic's standard intake procedures
  • 6. agree to maintain a stable schedule of concomitant psychiatric medications throughout the ketamine induction phase (minor adjustments to PRN meds and timing of meds are allowable), and for 4 weeks post-induction phase
  • 7. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
  • 8. be willing and able to provide names and contact information for at least 1 additional emergency contact in the patient's proximal geographic area (in addition to the ketamine treatment team at the enrolling site)

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Presence of current/acute psychosis, mania, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment (e.g., autism spectrum disorder)
  • 2. Current/acute suicide risk with intent to act, defined as CSSRS past-week ideation score ≥ 4 among outpatients; patients engaged in residential or inpatient care at the time of enrollment need not meet this CSSRS score criterion, as their current/acute suicide risk is extremely low by virtue of the residential/inpatient, round-the-clock care they are already receiving at time of enrollment
  • 3. Concern for dementia or significant cognitive decline, per interviewer observations and impressions during screening assessments
  • 4. Current pregnancy or breastfeeding
  • 5. English reading level <5th grade as per patient self-report Rationale: to ensure adequate reading comprehension for verbal ASAT/sham stimuli which are presented in English

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment600 participants
  • Timeline
    Start: 2024-11-01
    End: 2030-06-01
  • Topic
    Depressive Disorders

Locations

Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals — Oakland, California, United States
University of Illinois at Chicago — Chicago, Illinois, United States
Baylor College of Medicine — Houston, Texas, United States

Your Library