Suicidal IdeationPhase 2NCT05105061
Intramuscular Ketamine for Suicidal Ideation
A Phase 2 study testing Ketamine (Ketalar) in people with Suicidal Ideation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Ketamine (Ketalar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2022to 24 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
- Inpatient status at the time of study initiation.
- 18 to 70 years of age
- Capacity to consent
Who cannot join
- Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
- Diagnosis of pervasive developmental disorder
- Diagnosis of a major neurocognitive disorder
- A positive urine pregnancy test
- Currently breastfeeding
- Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
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- Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
- Medical issues or laboratory abnormalities requiring acute intervention
- Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
- Any lifetime history of ketamine or phencyclidine abuse
- A known hypersensitivity to or history of a serious adverse effect from to ketamine
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.
- Conditions
- Suicidal Ideation
- Being tested
- Ketamine (Ketalar), Placebo
- Keywords
- Suicide, EEG, Ketamine
- Medical subject headings
- Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (Ketalar)Drug
0.5 mg/kg of body weight
PlaceboDrug
IM injection of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketamine (1) then Placebo (2) | Experimental | Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo) Receives: Drug: Ketamine (Ketalar); Drug: Placebo |
| Placebo (1) then Ketamine (2) | Placebo comparator | Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine Receives: Drug: Ketamine (Ketalar); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Auditory Mismatch Negativity (EEG)
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
Measured: Baseline and One hour post injection
Secondary outcomes (1)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)
Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.
Measured: Baseline and 24 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startFeb 2022 (estimated)
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Klein, Icahn School of Medicine at Mount Sinai
- Investigators
- Matthew Klein, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105061
- Sponsor's protocol ID
- STUDY-20-01496
- Other IDs
- 21-1174
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
- ClinicalTrials.gov ID
- NCT05105061
- Acronym / sponsor ID
- STUDY-20-01496
- Conditions
- Suicidal Ideation
- Keywords
- Suicide, EEG, Ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 3 Nov 2021 (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.
The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine (1) then Placebo (2) | Experimental | Drug: Ketamine (Ketalar), Drug: PlaceboParticipants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo) |
| Placebo (1) then Ketamine (2) | Placebo comparator | Drug: Ketamine (Ketalar), Drug: PlaceboParticipants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
- Inpatient status at the time of study initiation.
- 18 to 70 years of age
- Capacity to consent
Key exclusion criteria (11 listed)
- Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
- Diagnosis of pervasive developmental disorder
- Diagnosis of a major neurocognitive disorder
- A positive urine pregnancy test
- Currently breastfeeding
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 |
|---|---|---|
| Ketamine (Ketalar)0.5 mg/kg of body weight | Drug | Ketamine (1) then Placebo (2), Placebo (1) then Ketamine (2) |
| PlaceboIM injection of matching placebo | Drug | Ketamine (1) then Placebo (2), Placebo (1) then Ketamine (2) |
Primary outcome
Change in Auditory Mismatch Negativity (EEG)
Time frame: Baseline and One hour post injection
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
1 secondary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)
Time frame: Baseline and 24 hours post injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Suicidal Ideation
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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.
Matthew Klein principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine (Ketalar) in people with Suicidal Ideation, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Apr 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Auditory Mismatch Negativity (EEG) (time frame: Baseline and One hour post injection). 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 5 Apr 2022.