Cognitive Training Added to Ketamine for Depression in Real-World Clinics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In patients already receiving ketamine/esketamine for depression in real-world clinics, researchers will add a computer-based cognitive training program to see if it can amplify and prolong the rapid antidepressant effects. The trial compares cognitive training to sham training as an adjunct to ketamine treatment. Eligibility targets adults 18–80 with confirmed major depressive disorder or related mood conditions and evidence of treatment resistance. The study uses a practical, clinic-based design across multiple sites to assess feasibility and potential benefit. This description reflects an interventional approach aiming to enhance brain plasticity during ketamine therapy.

Why it matters

Who can join: the full rules

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
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

Where it's running

• University of Illinois at Chicago
  Chicago, Illinois, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
  Oakland, California, United States Not yet recruiting

Study contacts

• Principal investigator: Rebecca B Price, PhD — University of Pittsburgh
• Study coordinator: Rebecca B Price, PhD
• Email: ketclinics@pitt.edu
• Phone: 412-383-2150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.