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

University of Pittsburgh

Status: Invitation-only

Conditions: Depression

Treatments: Behavioral: Sham Training; Behavioral: Cognitive Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06526078

R01MH136179 (U.S. NIH Grant/Contract)

R01MH136178 (U.S. NIH Grant/Contract)

STUDY23110120

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Cognitive Training

Experimental group

Description:

Web-based cognitive training

Treatment:

Behavioral: Cognitive Training

Sham Training

Sham Comparator group

Description:

Web-based sham training

Treatment:

Behavioral: Sham Training