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

NCT06526078 | Enrolling By Invitation DMC

• 3 other identifiers: STUDY23110120R01MH136179R01MH136178
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction

  depression severity; range 0-60; high score=worse outcome

  Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)

• Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction

  depression severity; range 0-60; high score=worse outcome

  Trajectories from final 'induction phase' treatment through 4 weeks post-induction

Secondary Outcomes (10)

• Quick Inventory of Depressive Symptoms

  Trajectories from baseline through 12 months post-induction

• PROMIS Measures-depression

  Trajectories from baseline through 12 months post-induction

• Beck Hopelessness Scale

  Trajectories from baseline through 12 months post-induction

• PROMIS Measures-anxiety

  Trajectories from baseline through 12 months post-induction

• PROMIS Measures-anger

  Trajectories from baseline through 12 months post-induction

Other Outcomes (17)

• Implicit Association Test

  Trajectories from baseline through 4 weeks post-induction

• Columbia Suicide Severity Rating Scale--Intensity of Most Severe Ideation

  Trajectories from baseline through 12 months post-induction

• Patient Health Care Utilization Survey (PHCUS)

  Trajectories from baseline through 12 months post-induction

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Web-based cognitive training

Behavioral: Cognitive Training

Sham Training

SHAM COMPARATOR

Web-based sham training

Behavioral: Sham Training

Interventions

Cognitive Training BEHAVIORAL

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

Cognitive Training

Sham Training BEHAVIORAL

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

Sham Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals

Oakland, California, 94612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rebecca B Price, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 29, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available one year after study completion and will be available indefinitely.
• Access Criteria: NDA access required.

Locations

US (3)