Suicide, AttemptedPhase 4NCT04578938
Ketamine + Cognitive Training for Suicidality in the Medical Setting
A Phase 4 study testing Intravenous ketamine and Cognitive training in people with Suicide, Attempted, run by Rebecca Price at 1 site in United States.
Trial summary
This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Intravenous ketamine and Cognitive training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 2 Dec 2026
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who receive ketamine will:
- be between the ages of 18 and 70 years
- be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
- 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 deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization
Who cannot join
- Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
- Mini-Mental State Exam (MMSE) < 21
- Current pregnancy or breastfeeding
- Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
- Past intolerance or hypersensitivity to ketamine or esketamine
- Patients taking St John's Wort
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- Patients who have received ECT in the past 1 month prior to intake
- Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
- Arrested or incarcerated individuals brought in by the legal system for medical stabilization
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
Read the detailed description
NOTE: Edits were made to the outcome measures sections to improve clarity regarding the a priori analytic plan with respect to the "Time Frame" of measurements and to reduce redundancies. Timepoints that will be analyzed as trajectories over windows of time and measurements that will be analyzed as composites are now more clearly specified. The previous entries correctly identified all relevant measures and timepoints, but implied incorrectly that each timepoint/measure would be analyzed in isolation.
03/19/26: Edit to upper age limit made to correct a previous data entry error and align with IRB-approved protocol.
- Conditions
- Suicide, Attempted
- Being tested
- Intravenous ketamine, Cognitive training, Sham Training
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ketamineDrug
Single subanesthetic infusion of ketamine (0.5mg/kg)
Cognitive trainingBehavioural
8 sessions of computer-based cognitive training
Sham TrainingBehavioural
8 sessions of computer-based sham training
| Study group | Role | What they receive |
|---|---|---|
| Ketamine + Cognitive Training | Experimental | Not described Receives: Drug: Intravenous ketamine; Behavioral: Cognitive training |
| Ketamine + Sham Training | Sham comparator | Not described Receives: Drug: Intravenous ketamine; Behavioral: Sham Training |
| No-infusion (TAU) + Cognitive Training | Active comparator | Not described Receives: Behavioral: Cognitive training |
| No-infusion (TAU) + Sham Training | Sham comparator | Not described Receives: Behavioral: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: Trajectories from 24hrs through 1 month
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from 24hrs through 1 month
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide
Measured: Trajectories from 24hrs through 12 months
Secondary outcomes (4)
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: Trajectories from 24hrs through 12 months
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from 24hrs through 12 months
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: Trajectories from 1 month through 12 months
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from 1 month through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Mar 2021
- Primary completion2 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Price
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Rebecca Price, University of Pittsburgh
- Investigators
- Rebecca B Price, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578938
- Sponsor's protocol ID
- STUDY19100041 (Part 2)
- Other IDs
- R01MH124983
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine + Cognitive Training for Suicidality in the Medical Setting
- ClinicalTrials.gov ID
- NCT04578938
- Acronym / sponsor ID
- STUDY19100041 (Part 2)
- Conditions
- Suicide, Attempted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rebecca PriceUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 8 Oct 2020 (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.
This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
Detailed description
NOTE: Edits were made to the outcome measures sections to improve clarity regarding the a priori analytic plan with respect to the "Time Frame" of measurements and to reduce redundancies. Timepoints that will be analyzed as trajectories over windows of time and measurements that will be analyzed as composites are now more clearly specified. The previous entries correctly identified all relevant measures and timepoints, but implied incorrectly that each timepoint/measure would be analyzed in isolation.
03/19/26: Edit to upper age limit made to correct a previous data entry error and align with IRB-approved protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Cognitive Training | Experimental | Drug: Intravenous ketamine, Behavioral: Cognitive training |
| Ketamine + Sham Training | Sham comparator | Drug: Intravenous ketamine, Behavioral: Sham Training |
| No-infusion (TAU) + Cognitive Training | Active comparator | Behavioral: Cognitive training |
| No-infusion (TAU) + Sham Training | Sham comparator | Behavioral: Sham Training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be between the ages of 18 and 70 years
- be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
- 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 deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization
Key exclusion criteria (9 listed)
- Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
- Mini-Mental State Exam (MMSE) < 21
- Current pregnancy or breastfeeding
- Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
- Past intolerance or hypersensitivity to ketamine or esketamine
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 |
|---|---|---|
| Intravenous ketamineSingle subanesthetic infusion of ketamine (0.5mg/kg) | Drug | Ketamine + Cognitive Training, Ketamine + Sham Training |
| Cognitive training8 sessions of computer-based cognitive training | Behavioural | Ketamine + Cognitive Training, No-infusion (TAU) + Cognitive Training |
| Sham Training8 sessions of computer-based sham training | Behavioural | Ketamine + Sham Training, No-infusion (TAU) + Sham Training |
Primary outcome
Scale for Suicide Ideation
Time frame: Trajectories from 24hrs through 1 month
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: Trajectories from 24hrs through 1 month
depression severity; range 0-60; high score=worse outcome
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: Trajectories from 24hrs through 12 months
composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide
4 secondary outcomes
Adult Suicide Ideation Questionnaire
Time frame: Trajectories from 24hrs through 12 months
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from 24hrs through 12 months
Scale for Suicide Ideation
Time frame: Trajectories from 1 month through 12 months
Montgomery Asberg Depression Rating Scale
Time frame: Trajectories from 1 month through 12 months
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rebecca B Price, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous ketamine and Cognitive training in people with Suicide, Attempted, run by Rebecca Price at 1 site 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicide Ideation (time frame: Trajectories from 24hrs through 1 month). The study lists 3 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 24 Mar 2026.