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Cognitive Training as an Adjunct to Ketamine in Real-world Clinics | Clinical Trials | Clareo Health

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

A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect

NCT06526078•University of Pittsburgh

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (3)

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

Key Dates

Start Date

November 12, 2024

Primary Completion Date

May 31, 2029

Completion Date

May 31, 2029

Last Updated

November 21, 2025

Enrollment

600

ESTIMATED participants

Conditions

Depression

Interventions

Cognitive Training

BEHAVIORAL

Sham Training

BEHAVIORAL

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Readiness and Progress in Emotion Regulation Therapy

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression

Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures