Status:
ENROLLING_BY_INVITATION
Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-80 years
Phase:
NA
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 effect...
Eligibility Criteria
Inclusion
- be between the ages of 18 and 80 years
- score ≥20 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- 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
- 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)
- 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
- 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
- possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
- 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
- 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)
- 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
- Concern for dementia or significant cognitive decline, per interviewer observations and impressions during screening assessments
- Current pregnancy or breastfeeding
- 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
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06526078
Start Date
November 12 2024
End Date
May 31 2029
Last Update
November 21 2025
Active Locations (3)
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1
Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
Oakland, California, United States, 94612
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
3
Baylor College of Medicine
Houston, Texas, United States, 77030