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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether computer-based thinking and learning exercises can boost or extend the fast effects of ketamine or esketamine. It is for adults with depression or bipolar disorder who are already set to receive this treatment at a study clinic.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old.
  • Score at least 20 on the MADRS, a scale that measures depression symptoms.
  • Have depression or bipolar disorder confirmed in a study interview, including one of the types listed in the study.
  • Have tried at least one treatment for a mood disorder or PTSD that did not help enough, or been unable to tolerate a mood disorder treatment.
  • Be approved and enrolled to start a ketamine or esketamine treatment series at a study clinic.
  • Keep your mental health medicines on a stable schedule during the treatment series and for 4 weeks after. Small changes to as-needed medicines or medicine timing are allowed.
  • Be able to understand and agree to the study steps, and sign a consent form.
  • Provide the name and contact details of at least one nearby emergency contact besides your ketamine care team.

Who can't join

  • Currently have psychosis (trouble knowing what is real), mania (an unusually high-energy or irritable mood), or dementia (loss of memory and thinking skills).
  • Have a developmental disorder with major language or learning difficulties.
  • For outpatients, have a current risk of suicide with intent to act, based on a past-week suicide screening score of at least 4. This score rule does not apply to people receiving round-the-clock inpatient or residential care.
  • Show signs during screening that raise concern about dementia or a major decline in thinking skills.
  • Be pregnant.
  • Report reading English below a 5th-grade level.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (3)

CA

IL

TX