Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Training
BehavioralSessions of cognitive training exercises (15-20min each) self-administered via a web app
Sham Training
BehavioralSessions of sham training exercises (15-20min each) self-administered via a web app
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Cognitive TrainingExperimental treatment 1 intervention
Group B: Sham TrainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Time frame
Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)2
Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Time frame
Trajectories from final 'induction phase' treatment through 4 weeks post-inductionSecondary outcomes
1
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame
Trajectories from baseline through 12 months post-induction2
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Time frame
Trajectories from baseline through 12 months post-induction3
Beck Hopelessness Scale
self reported to measure key aspects of hopelessness; range = 0-20, higher score=worse outcome
Time frame
Trajectories from baseline through 12 months post-induction4
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Time frame
Trajectories from baseline through 12 months post-inductionOther outcomes
1
Implicit Association Test
performance-based "target engagement" measure of implicit self-esteem; range = -inf-inf; high score=worse outcome
Time frame
Trajectories from baseline through 4 weeks post-induction2
Columbia Suicide Severity Rating Scale--Intensity of Most Severe Ideation
suicidal ideation/thoughts; range 0-5; high score=worse outcome
Time frame
Trajectories from baseline through 12 months post-induction3
Patient Health Care Utilization Survey (PHCUS)
interview measure of psychiatric and healthcare service utilization
Time frame
Trajectories from baseline through 12 months post-induction4
PROMIS Measures-substance Use
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome)
Time frame
Trajectories from baseline through 12 months post-inductionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov