DepressionNCT06526078
Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
A study testing Cognitive Training in people with Depression, run by University of Pittsburgh at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2024to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Alex Leow, MD, alexfeuillet@gmail.com
Sarah Kabir, skabir4@uic.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Sanjay Mathew, MD, sjmathew@bcm.edu
Julia Engelhardt, julia.engelhardt@bcm.edu
- Not yet recruiting
Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
Oakland, California, 94612
Steven Hamilton, MD, Steven.P.Hamilton@kp.org
Gabby Sanchez, Gabriela.X.Sanchez@kp.org
About this study
Official title: A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect
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.
- Conditions
- Depression
- Being tested
- Cognitive Training, Sham Training
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Sessions of cognitive training exercises (15-20min each) self-administered via a web app
Sham TrainingBehavioural
Sessions of sham training exercises (15-20min each) self-administered via a web app
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Web-based cognitive training Receives: Behavioral: Cognitive Training |
| Sham Training | Sham comparator | Web-based sham training Receives: Behavioral: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)
Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from final 'induction phase' treatment through 4 weeks post-induction
Secondary outcomes (10)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from baseline through 12 months post-induction
Beck Hopelessness Scale
self reported to measure key aspects of hopelessness; range = 0-20, higher score=worse outcome
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anger
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Positive Affect
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Measured: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Cognitive Function
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Measured: Trajectories from baseline through 12 months post-induction
Cognitive Triad Inventory
Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
Measured: Trajectories from baseline through 12 months post-induction
Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from baseline through 12 months post-induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start12 Nov 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Price, University of Pittsburgh
- Investigators
- Rebecca B Price, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526078
- Sponsor's protocol ID
- STUDY23110120
- Other IDs
- R01MH136179, R01MH136178
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results will be shared with other researchers via the NIMH Data Archive (NDA) data repository.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Automated Neurocognitive Training to Enhance the Real-World Impact of Ketamine's Rapid Antidepressant Effect
- ClinicalTrials.gov ID
- NCT06526078
- Acronym / sponsor ID
- STUDY23110120
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingWeb-based cognitive training |
| Sham Training | Sham comparator | Behavioral: Sham TrainingWeb-based sham training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingSessions of cognitive training exercises (15-20min each) self-administered via a web app | Behavioural | Cognitive Training |
| Sham TrainingSessions of sham training exercises (15-20min each) self-administered via a web app | Behavioural | Sham Training |
Primary outcome
Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction
Time frame: Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction
Time frame: Trajectories from final 'induction phase' treatment through 4 weeks post-induction
depression severity; range 0-60; high score=worse outcome
10 secondary outcomes
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-depression
Time frame: Trajectories from baseline through 12 months post-induction
Beck Hopelessness Scale
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anxiety
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anger
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Positive Affect
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Sleep Disturbance
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Cognitive Function
Time frame: Trajectories from baseline through 12 months post-induction
Cognitive Triad Inventory
Time frame: Trajectories from baseline through 12 months post-induction
Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up
Time frame: Trajectories from baseline through 12 months post-induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results will be shared with other researchers via the NIMH Data Archive (NDA) data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca B Price, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Depression, run by University of Pittsburgh at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca B Price, PhD (412-383-2150, ketclinics@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction (time frame: Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.