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

NCT ID: NCT06526078

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2029-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cognitive Training

Web-based cognitive training

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: BEHAVIORAL

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

Sham Training

Web-based sham training

Group Type: SHAM_COMPARATOR

Sham Training

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Training

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

Intervention Type: BEHAVIORAL

Sham Training

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

Intervention Type: BEHAVIORAL

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 an upcoming ketamine or esketamine induction series 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Price

Associate Professor of Psychiatry and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca B Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

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

Countries

United States

Other Identifiers

R01MH136179

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH136178

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY23110120

Identifier Type: -

Identifier Source: org_study_id