Suicide, AttemptedPhase 4NCT04154150

Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 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: 16 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2019to 15 Mar 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants will:
be between the ages of 18 and 65 years
be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
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 psychotic or autism spectrum disorder or current delirium
Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
Current pregnancy or breastfeeding
Reading level <5th grade as per WRAT-3 reading subtest
Past intolerance or hypersensitivity to ketamine
Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide

Show all 9Show fewer

Patients who have received ECT in the past 6 months prior to intake
Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
Patients who, based on expressed preference and/or home geographic location, are deemed by the Psychiatric Consultation/Liaison service to be likely to receive inpatient psychiatric hospitalization at an alternate location outside of Western Psychiatric Institute \& Clinic

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

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: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.

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 groups in NCT04154150
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

What is being measured

The primary outcome is the main question the study is designed to answer.

Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +24 hours
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +5 days
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +12 days
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +1 month
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +3 months
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Measured: infusion +6 months
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +24 hours
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +5 days
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +12 days
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +1 month
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +3 months
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Measured: infusion +6 months

Secondary outcomes (14)

Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review
Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide
Measured: infusion +6 months
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)
Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses.
Measured: infusion +6 months
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +24 hours
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +5 days
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +12 days
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +1 month
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +3 months
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: infusion +6 months
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +24 hours
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +5 days
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +12 days
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +1 month
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +3 months
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Measured: infusion +6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 201915 Mar 2022

First posted6 Nov 2019
Study start19 Dec 2019
Primary completion15 Mar 2022
Study completion15 Mar 2022

Why it stopped: Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04154150
Sponsor's protocol ID: STUDY19100041 (Part 1)
Status last verified: Jul 2024
First submitted: 4 Nov 2019
Last updated: 22 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide, Attempted trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
ClinicalTrials.gov ID: NCT04154150
Acronym / sponsor ID: STUDY19100041 (Part 1)
Conditions: Suicide, Attempted
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.
Enrolment: 16 participants (actual)
Lead sponsor: Rebecca PriceUniversity, hospital or other
Study start: 19 Dec 2019 (actual)
Primary completion: 15 Mar 2022 (actual)
Study completion: 15 Mar 2022 (actual)
First posted: 6 Nov 2019 (actual)
Results: Posted 10 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ketamine + Cognitive Training	Experimental	Drug: Intravenous ketamine, Behavioral: Cognitive training
Ketamine + Sham Training	Sham comparator	Drug: Intravenous ketamine, Behavioral: Sham Training

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

be between the ages of 18 and 65 years
be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
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 psychotic or autism spectrum disorder or current delirium
Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
Current pregnancy or breastfeeding
Reading level <5th grade as per WRAT-3 reading subtest
Past intolerance or hypersensitivity to ketamine

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
Sham Training8 sessions of computer-based sham training	Behavioural	Ketamine + Sham Training

Primary outcome

Montgomery Asberg Depression Rating Scale
Time frame: infusion +24 hours
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: infusion +5 days
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: infusion +12 days
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: infusion +1 month
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: infusion +3 months
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
Time frame: infusion +6 months
depression severity; range 0-60; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
Time frame: infusion +24 hours
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
Time frame: infusion +5 days
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
Time frame: infusion +12 days
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
Time frame: infusion +1 month
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
Time frame: infusion +3 months
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
Time frame: infusion +6 months
suicidal ideation/thoughts; range 0-150; high score=worse outcome

14 secondary outcomes

Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review
Time frame: infusion +6 months
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: infusion +6 months
Quick Inventory of Depressive Symptoms
Time frame: infusion +24 hours
Quick Inventory of Depressive Symptoms
Time frame: infusion +5 days
Quick Inventory of Depressive Symptoms
Time frame: infusion +12 days
Quick Inventory of Depressive Symptoms
Time frame: infusion +1 month
Quick Inventory of Depressive Symptoms
Time frame: infusion +3 months
Quick Inventory of Depressive Symptoms
Time frame: infusion +6 months
Scale for Suicide Ideation
Time frame: infusion +24 hours
Scale for Suicide Ideation
Time frame: infusion +5 days
Scale for Suicide Ideation
Time frame: infusion +12 days
Scale for Suicide Ideation
Time frame: infusion +1 month
Scale for Suicide Ideation
Time frame: infusion +3 months
Scale for Suicide Ideation
Time frame: infusion +6 months

Results and safety

Results posted to the registry on 10 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketamine + Cognitive Training	7	7
Ketamine + Sham Training	9	9

Primary outcome: Montgomery Asberg Depression Rating Scale

Time frame: infusion +24 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketamine + Cognitive Training n = 7	Ketamine + Sham Training n = 9
Value	18.43 (8.5)	15.44 (10.9)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery Asberg Depression Rating Scale

Time frame: infusion +5 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketamine + Cognitive Training n = 7	Ketamine + Sham Training n = 8
Value	19.14 (9.8)	16.13 (9.2)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery Asberg Depression Rating Scale

Time frame: infusion +12 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketamine + Cognitive Training n = 3	Ketamine + Sham Training n = 7
Value	13.67 (14.2)	17.29 (11.9)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Primary outcome: Montgomery Asberg Depression Rating Scale

Time frame: infusion +1 month. Mean (Standard Deviation). Unit: score on a scale

Measure	Ketamine + Cognitive Training n = 3	Ketamine + Sham Training n = 6
Value	20.67 (7.6)	14.00 (13.4)

Population analysed: All participants who were assigned to the arm and were willing and able to complete this specific measure.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketamine + Cognitive Training	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Ketamine + Sham Training	0 of 9 (0%)	9 of 9 (100%)	0 of 9

Limitations and caveats (from the sponsor): Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

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: stopped early, as of the sponsor's last update on 22 Jul 2024. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Montgomery Asberg Depression Rating Scale (time frame: infusion +24 hours). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04154150.

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 22 Jul 2024.