Suicide, AttemptedPhase 3NCT04763343
Ketamine Treatment of Youth Suicide Attempters
A Phase 3 study testing Ketamine Hydrochloride, Saline and CAMS Therapy in people with Suicide, Attempted, run by Tatiana Falcone, MD at 1 site in United States.
Trial summary
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. Read more about this study
- Who is it for?
- Ages 14 to 30 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Ketamine Hydrochloride, Saline and CAMS Therapy
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 28 Feb 2027
- Phase
- Phase 3
- 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 14 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be 14 to 30 years of age
- Subjects must have been admitted to Cleveland Clinic Hospital (Fairview or Lutheran Hospital) after a suicide attempt (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was indicated) with continued suicidal ideation or endorsing ongoing suicidal ideation and unable to contract for safety placing them at an increased risk to attempt suicide. Subjects will need a clinical rated Scale for Suicidal Ideation (SSI) score ≥ 6.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects with known history of autistic spectrum disorder; non-verbal patients.
- Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education full-time).
- Subjects with schizophrenia or history of any type of psychosis including mood disorder related psychosis and brief reactive psychosis.
- Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for management of ADHD will not be excluded)
- Subjects with history of moderate or severe substance or alcohol use per DSM- V criteria in the past 6 months.
- Subjects with any contraindication to ketamine such as allergic reaction to ketamine or medical or neurological condition with a contraindication for use of ketamine or on any drugs associated with significant interaction with ketamine.
Show all 10Show fewer
- Subjects who are currently pregnant and/or breast feeding.
- Subjects with previous recreational ketamine use. Subjects with previous therapeutic Ketamine use that exceeds the maximum cumulative lifetime exposure of 60 mg daily and 8 administrations maximum (or 480 mg) during both previous treatment and the proposed inclusion of this study.
- Subjects with hypertension, history of myocardial infarction, congestive heart failure of Stage 2 or higher, angina, or QTcF of at least 450 msec as indicated by chart review and/or standard of care EKG performed upon admission to inpatient unit.
- Subjects in the custody of Children's Services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Cleveland Clinic
Cleveland, Ohio, 44195
Tatiana Falcone, M.D., 216-444-7459, falcont1@ccf.org
About this study
Official title: Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Double Blind Randomized Placebo Controlled Trial
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 60 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).
Read the detailed description
Suicide is the second leading cause of death in 15-24 year-olds and accounts for 13% of all adolescent deaths annually. According to the CDC, the suicide rate for 10-24 year-olds increased in the last decade, with the suicide rate for 10-14 year-olds, 15-18 year-olds, and 20-24 year-olds increasing 177%, 76%, and 36%, respectfully. There is a critical need to develop fast and effective treatment in this highest-risk age group. Therefore, there is an urgent need to develop rapid, safe and feasible treatment to decrease suicidality in youth admitted to inpatient psychiatry after a serious suicidal attempt.
This proposal seeks to address this critical clinical gap by conducting an inpatient trial of treatment with ketamine vs placebo (saline) for rapid reversal of patients' suicidal state. Furthermore, this study will also test whether ketamine facilitates the effectiveness of collaborative psychotherapy for an enduring anti-suicidal response. One hundred and forty subjects who are medically stable admitted to inpatient psychiatry after a serious suicide attempt (defined as any act of self-harm with an intent to die) with continued suicidal ideation will be included in the study. After initial assessment, in conjunction with an anesthesiologist for any contraindication of using ketamine, patients will be randomized to receive either ketamine infusion 0.5 mg/kg over 40 minutes or saline. Ketamine or saline infusions on alternate days over two weeks will be given until subject reports no suicidal ideation for three consecutive sessions, or a maximum administration of six infusions is reached, or until they are discharged from the hospital. Concurrently, weekly sessions of CAMS will be started and continued as an outpatient after the patient is discharged until the subject also reports no suicidal ideation as an outpatient for three consecutive sessions. Monthly assessments for suicidal ideation, attempts and readmissions will be conducted as an outpatient for 3 months.
- Conditions
- Suicide, Attempted
- Being tested
- Ketamine Hydrochloride, Saline, CAMS Therapy
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Ketamine hydrochloride will be given as an intravenous infusion using a standard regimen given in most studies conducted: 0.5 mg/kg over 40 minutes. Ketamine infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
SalineDrug
Subjects randomized to placebo will be administered a saline (0.9% sodium chloride) drip for 40 minutes. Saline placebo infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
CAMS TherapyBehavioural
CAMS weekly sessions will also be started immediately as an inpatient at the start of the study while receiving ketamine or saline. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Treatment + CAMS Therapy | Experimental | Not described Receives: Drug: Ketamine Hydrochloride; Behavioral: CAMS Therapy |
| Saline Placebo Treatment + CAMS Therapy | Placebo comparator | Not described Receives: Drug: Saline; Behavioral: CAMS Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of remission of suicidal symptoms at the end of treatment.
Remission of suicide symptoms will be defined by a 50% or greater reduction in the clinician-rated baseline Beck Scale for Suicidal Ideation (SSI) score, and SSI score less than the score of 4. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation. The primary outcome of the remission rate will be compared between the two groups.
Measured: Up to 3 months post-discharge
Secondary outcomes (2)
Number of CAMS sessions needed to achieve enduring mental state
Number of CAMS sessions needed to achieve enduring mental state
Measured: Up to 3 months post-discharge
Change of Beck Scale for Suicide Ideation score will be analyzed
Change of Beck Scale for Suicide Ideation (SSI) score will be analyzed. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation.
Measured: Up to 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start27 Jun 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tatiana Falcone, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), Massachusetts General Hospital
- Responsible party
- Sponsor-investigator, Tatiana Falcone, MD, The Cleveland Clinic
- Investigators
- Tatiana Falcone, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763343
- Sponsor's protocol ID
- 21-154
- Other IDs
- 1R01MH125214-01
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reilly-Harrington NA, Falcone T, Jobes DA, Deisz C, Flannery C, Wolf A, Hu B, Anand A. Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol. Contemp Clin Trials. 2025 Feb;149:107777. doi: 10.1016/j.cct.2024.107777. Epub 2024 Dec 12.
PubMed 39672260
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Double Blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04763343
- Acronym / sponsor ID
- 21-154
- Conditions
- Suicide, Attempted
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tatiana Falcone, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), Massachusetts General Hospital
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 21 Feb 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.
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 60 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).
Detailed description
Suicide is the second leading cause of death in 15-24 year-olds and accounts for 13% of all adolescent deaths annually. According to the CDC, the suicide rate for 10-24 year-olds increased in the last decade, with the suicide rate for 10-14 year-olds, 15-18 year-olds, and 20-24 year-olds increasing 177%, 76%, and 36%, respectfully. There is a critical need to develop fast and effective treatment in this highest-risk age group. Therefore, there is an urgent need to develop rapid, safe and feasible treatment to decrease suicidality in youth admitted to inpatient psychiatry after a serious suicidal attempt.
This proposal seeks to address this critical clinical gap by conducting an inpatient trial of treatment with ketamine vs placebo (saline) for rapid reversal of patients' suicidal state. Furthermore, this study will also test whether ketamine facilitates the effectiveness of collaborative psychotherapy for an enduring anti-suicidal response. One hundred and forty subjects who are medically stable admitted to inpatient psychiatry after a serious suicide attempt (defined as any act of self-harm with an intent to die) with continued suicidal ideation will be included in the study. After initial assessment, in conjunction with an anesthesiologist for any contraindication of using ketamine, patients will be randomized to receive either ketamine infusion 0.5 mg/kg over 40 minutes or saline. Ketamine or saline infusions on alternate days over two weeks will be given until subject reports no suicidal ideation for three consecutive sessions, or a maximum administration of six infusions is reached, or until they are discharged from the hospital. Concurrently, weekly sessions of CAMS will be started and continued as an outpatient after the patient is discharged until the subject also reports no suicidal ideation as an outpatient for three consecutive sessions. Monthly assessments for suicidal ideation, attempts and readmissions will be conducted as an outpatient for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Treatment + CAMS Therapy | Experimental | Drug: Ketamine Hydrochloride, Behavioral: CAMS Therapy |
| Saline Placebo Treatment + CAMS Therapy | Placebo comparator | Drug: Saline, Behavioral: CAMS Therapy |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subjects must be 14 to 30 years of age
- Subjects must have been admitted to Cleveland Clinic Hospital (Fairview or Lutheran Hospital) after a suicide attempt (any intentional, non-fatal self- injury regardless of medical lethality, if intent to die was indicated) with continued suicidal ideation or endorsing ongoing suicidal ideation and unable to contract for safety placing them at an increased risk to attempt suicide. Subjects will need a clinical rated Scale for Suicidal Ideation (SSI) score ≥ 6.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (10 listed)
- Subjects with known history of autistic spectrum disorder; non-verbal patients.
- Subjects with moderate or severe intellectual disability (IQ less than 70 and those patients in special education full-time).
- Subjects with schizophrenia or history of any type of psychosis including mood disorder related psychosis and brief reactive psychosis.
- Within 6 months before initial screening, urine toxicology positive for phencyclidine, cocaine or amphetamines (subjects prescribed amphetamines for management of ADHD will not be excluded)
- Subjects with history of moderate or severe substance or alcohol use per DSM- V criteria in the past 6 months.
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 HydrochlorideKetamine hydrochloride will be given as an intravenous infusion using a standard regimen given in most studies conducted: 0.5 mg/kg over 40 minutes. Ketamine infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit. | Drug | Ketamine Treatment + CAMS Therapy |
| SalineSubjects randomized to placebo will be administered a saline (0.9% sodium chloride) drip for 40 minutes. Saline placebo infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit. | Drug | Saline Placebo Treatment + CAMS Therapy |
| CAMS TherapyCAMS weekly sessions will also be started immediately as an inpatient at the start of the study while receiving ketamine or saline. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior). | Behavioural | Ketamine Treatment + CAMS Therapy, Saline Placebo Treatment + CAMS Therapy |
Primary outcome
Rate of remission of suicidal symptoms at the end of treatment.
Time frame: Up to 3 months post-discharge
Remission of suicide symptoms will be defined by a 50% or greater reduction in the clinician-rated baseline Beck Scale for Suicidal Ideation (SSI) score, and SSI score less than the score of 4. SSI scores can range from 0 to 38, and a higher score indicates increased severity of suicidal ideation. The primary outcome of the remission rate will be compared between the two groups.
2 secondary outcomes
Number of CAMS sessions needed to achieve enduring mental state
Time frame: Up to 3 months post-discharge
Change of Beck Scale for Suicide Ideation score will be analyzed
Time frame: Up to 3 months post-discharge
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 16 Jul 2026.
- Derived from this study: PubMed 39672260Reilly-Harrington NA, Falcone T, Jobes DA, Deisz C, Flannery C, Wolf A, Hu B, Anand A. Ketamine treatment in youth for fast reduction of suicidality and engagement in psychotherapy: A randomized placebo-controlled trial protocol. Contemp Clin Trials. 2025 Feb;149:107777. doi: 10.1016/j.cct.2024.107777. Epub 2024 Dec 12.
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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.
Tatiana Falcone, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine Hydrochloride, Saline and CAMS Therapy in people with Suicide, Attempted, run by Tatiana Falcone, MD 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 3 inclusion and 10 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 16 Jul 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 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?
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 Christina Deisz, LISW-S ((440) 225-6193, deiszc@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of remission of suicidal symptoms at the end of treatment. (time frame: Up to 3 months post-discharge). 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 NCT04763343, 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 16 Jul 2026.