DepressionPhase 2/3NCT02183272
Emergency Ketamine Treatment of Suicidal Ideation
A Phase 2/3 study testing Intranasal Ketamine in people with Depression and Suicidal Ideation, run by University of Cincinnati at 1 site in United States.
Trial summary
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Suicidal Ideation, Suicidal Impulses
- What is being tested?
- Intranasal Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jul 2018
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- Ages 18-65
- All races and ethnicities
- Willing and able to provide informed consent
- A cutoff score of >3 on the Beck Scale for Suicidal Ideation
- >2 on the Columbia Scale for Suicide Severity Rating
Who cannot join
- Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
- Post-partum state (within 2 months of delivery)
- Homicide risk as determined by clinical interview
- Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
- Any current primary psychotic disorder
- Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
Show all 15Show fewer
- use of any hallucinogen (except cannabis), in the last month
- Any dissociative disorder
- Pervasive developmental disorder
- Cognitive disorder
- Cluster A personality disorder
- Anorexia nervosa.
- Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
- Any known hypersensitivity or serious adverse effect with ketamine
- Any clinically-significant medication or condition that would preclude the use of ketamine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Faryal Mallick, MD, 513-558-4997, mallicfl@ucmail.uc.edu
Cheryl McCullumsmith, MD PhD
About this study
Official title: Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.
Read the detailed description
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment
- Conditions
- Depression, Suicidal Ideation, Suicidal Impulses
- Being tested
- Intranasal Ketamine, Intranasal Saline Placebo
- Keywords
- Depression, Suicidal Ideation, Ketamine, Emergency Department
- Medical subject headings
- Depression, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal KetamineDrug
Also called ketamine
Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
Intranasal Saline PlaceboDrug
Also called saline
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketamine | Active comparator | 0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital. Receives: Drug: Intranasal Ketamine |
| Intranasal Saline Placebo | Placebo comparator | 0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission. Receives: Drug: Intranasal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketamine effect on Suicidal Ideation and Depression.
To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.
Measured: 4 weeks
Secondary outcomes (1)
Assessment of Role of Mu Opioid Receptor
To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 2016
- Primary completionNov 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl McCullumsmith, University of Cincinnati
- Investigators
- Cheryl McCullumsmith, MD PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183272
- Sponsor's protocol ID
- Ketamine IIT
- Status last verified
- Aug 2016
- First submitted
- 2 Jul 2014
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Domany Y, McCullumsmith CB. Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial. Arch Suicide Res. 2022 Jul-Sep;26(3):1250-1265. doi: 10.1080/13811118.2021.1878078. Epub 2021 Feb 14.
PubMed 33583341
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
- ClinicalTrials.gov ID
- NCT02183272
- Acronym / sponsor ID
- Ketamine IIT
- Conditions
- Depression, Suicidal Ideation, Suicidal Impulses
- Keywords
- Depression, Suicidal Ideation, Ketamine, Emergency Department
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 8 Jul 2014 (estimated)
- 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 current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.
Detailed description
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketamine | Active comparator | Drug: Intranasal Ketamine0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital. |
| Intranasal Saline Placebo | Placebo comparator | Drug: Intranasal Saline Placebo0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females
- Ages 18-65
- All races and ethnicities
- Willing and able to provide informed consent
- A cutoff score of >3 on the Beck Scale for Suicidal Ideation
Key exclusion criteria (15 listed)
- Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
- Post-partum state (within 2 months of delivery)
- Homicide risk as determined by clinical interview
- Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
- Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
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 |
|---|---|---|
| Intranasal KetamineAlso: ketamineKetamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation. | Drug | Intranasal Ketamine |
| Intranasal Saline PlaceboAlso: salineIntranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation. | Drug | Intranasal Saline Placebo |
Primary outcome
Ketamine effect on Suicidal Ideation and Depression.
Time frame: 4 weeks
To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.
1 secondary outcome
Assessment of Role of Mu Opioid Receptor
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 33583341Domany Y, McCullumsmith CB. Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial. Arch Suicide Res. 2022 Jul-Sep;26(3):1250-1265. doi: 10.1080/13811118.2021.1878078. Epub 2021 Feb 14.
- 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.
Cheryl McCullumsmith, MD PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intranasal Ketamine in people with Depression and Suicidal Ideation, run by University of Cincinnati 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Aug 2016. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faryal Mallick (513-558-4997, mallicfl@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketamine effect on Suicidal Ideation and Depression. (time frame: 4 weeks). 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 NCT02183272, which also lists 1 linked publication.
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 Aug 2016.