Clinical trial NCT06526078: Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
Official title: A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a sample of patients already receiving ketamine treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend 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: 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:

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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale: During Ketamine Induction
timeFrame: Trajectories from baseline through end of 'induction phase' infusions (up to max of 12 weeks)
measure: Montgomery Asberg Depression Rating Scale: After Ketamine Induction
timeFrame: Trajectories from final 'induction phase' infusion through 4 weeks post-induction
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-depression
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Beck Hopelessness Scale
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-anxiety
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-anger
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-Positive Affect
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-Sleep Disturbance
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-Cognitive Function
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Cognitive Triad Inventory
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up
timeFrame: Trajectories from baseline through 12 months post-induction
Other outcomes:
measure: Implicit Association Test
timeFrame: Trajectories from baseline through 4 weeks post-infusions
measure: Columbia Suicide Severity Rating Scale--Intensity of Most Severe Ideation
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Patient Health Care Utilization Survey (PHCUS)
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-substance Use
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-alcohol
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Acceptability, Appropriateness, and Feasibility
timeFrame: Post-CT assessment (approximately 5 days post infusion)
measure: Short Form Health Survey
timeFrame: Baseline through 12 months post-induction
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-CT assessment (approximately 5 days post infusion)
measure: mHealth App Usability Questionnaire (MAUQ)
timeFrame: 12 months post-induction
measure: Qualitative interviews assessing implementation
timeFrame: 12 months post-induction
measure: Compliance with prescribed cognitive training sessions
timeFrame: Post-CT timepoint (approximately 5 days post infusion)
measure: PROMIS Measures-Social Functioning
timeFrame: Trajectories from baseline through 12 months post-induction
measure: PROMIS Measures-Pain
timeFrame: Trajectories from baseline through 12 months post-induction
measure: Awe Experience Scale (AWE-S)
timeFrame: 24 hours post-infusion
measure: Implicit Association Test across follow-up
timeFrame: Trajectories through 12 months post-induction
measure: Time to relapse
timeFrame: Baseline through 12 months post-induction
measure: Time to first maintenance infusion
timeFrame: Baseline through 12 months post-induction
Locations:
city: Oakland
country: United States
facility: Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
state: California
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Rebecca B Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: