Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
ID: NCT06526078
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
Sessions of cognitive training exercises (15-20min each) self-administered via a web app
Sessions of sham training exercises (15-20min each) self-administered via a web app
Treatment Arms Description
Web-based cognitive training
Web-based sham training
- be between the ages of 18 and 80 years
- score ≥20 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- 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
- 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)
- be eligible and clinically enrolled for an upcoming ketamine or esketamine induction series at one of our study clinics according to that clinic's standard intake procedures
- 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
- possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
- 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)
- 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)
- 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
- Concern for dementia or significant cognitive decline, per interviewer observations and impressions during screening assessments
- Current pregnancy
- 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
Primary Outcome Measures
- Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction — Time Frame: Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)
depression severity; range 0-60; high score=worse outcome
- Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction — Time Frame: Trajectories from final 'induction phase' treatment through 4 weeks post-induction
depression severity; range 0-60; high score=worse outcome
View Secondary Outcome Measures (10)
- Quick Inventory of Depressive Symptoms — Time Frame: Trajectories from baseline through 12 months post-induction
Self-reported depression (range: 0-27; higher scores = worse outcome)
- PROMIS Measures-depression — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
- Beck Hopelessness Scale — Time Frame: Trajectories from baseline through 12 months post-induction
self reported to measure key aspects of hopelessness; range = 0-20, higher score=worse outcome
- PROMIS Measures-anxiety — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
- PROMIS Measures-anger — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
- PROMIS Measures-Positive Affect — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
- PROMIS Measures-Sleep Disturbance — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
- PROMIS Measures-Cognitive Function — Time Frame: Trajectories from baseline through 12 months post-induction
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
- Cognitive Triad Inventory — Time Frame: Trajectories from baseline through 12 months post-induction
Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
- Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up — Time Frame: Trajectories from baseline through 12 months post-induction
depression severity; range 0-60; high score=worse outcome
This trial is recruiting at 3 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 3 Facilities & Contact Sites
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
View Official Medical/Scientific Title
A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect