Suicidal IdeationPhase 3KETISNCT02299440
Effects of Ketamine in the Acute Phase of Suicidal Ideation
A Phase 3 study testing Baseline evaluation, 1st perfusion of ketamine and 1st perfusion of saline in people with Suicidal Ideation, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.
Trial summary
The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Baseline evaluation, 1st perfusion of ketamine and 1st perfusion of saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 9 sitesFrance
- Study dates
- Apr 2015to 21 Nov 2019
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French speaking patients freely hospitalized for prevention of suicide and who have a medium or high suicide risk score according to a MINI structured interview
- The patient is able to understand how the study is carried out and the tests performed
- The patient is deemed capable of giving his/her informed consent
- The patient has been correctly informed
- The patient must have given his/her informed and signed consent.
- The patient must be insured or beneficiary of a health insurance plan.
- Presence of suicidal ideation according to the SSI score (score > 3)
- Negative pregnancy test for women of childbearing age
Who cannot join
- The patient is participating in another interventional study
- Within the past three months, the patient has participated in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
Show all 18Show fewer
- The patient is not able to understand the informed consent
- Pregnancy or breastfeeding
- History of schizophrenia or other psychotic disorders
- Presence of psychotic symptoms at initial interview
- Schizoid or schizotypic personality disorder
- Positive urine screening for illicit substances, excluding cannabis
- Substance dependence in the preceding month (excluding nicotine or caffeine)
- Concomitant treatment with electroconvulsive therapy
- Unstable somatic pathology
- Clinically significant anomalies found during clinical examination, biological test or ECG
- Non-stabilized hypertension or hypertension > 180/100
- Known or suspected contra-indication for ketamine (includes interactions): hypersensitivity to ketamine, hypertension, class IV cardiac insufficiency, history of stroke, hepatic or cutaneous porphyria, history of intracranial hypertension
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, 63003
CHRU de Lille - Hôpital Michel Fontan
Lille, 59037
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
Clinique Les Sophoras
Nîmes, 30000
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
APHP - Hôpital Lariboisière
Paris, 75010
Centre Hospitalier Sainte-Anne
Paris, 75674
CMME Centre Hospitalier Sainte Anne
Paris, 75674
CHRU de Tours - Clinique Psychiatrique Universitaire
Saint-Cyr-sur-Loire, 37540
About this study
Official title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
The primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.
Read the detailed description
The secondary objectives of this study are to assess:
- The maintenance of medium-term effectiveness of ketamine on the resolution of suicidal ideation
- The evolution of the full spectrum of suicidality under ketamine compared to placebo
- The evolution of psychic and physical pain scores under ketamine compared to placebo
- The evolution of Beck Hopelessness score which is a predictor of long-term suicide risk, under ketamine compared to placebo
- The early antidepressant efficacy of ketamine in depressed, uni- or bipolar patients
- The somatic and psychological tolerance of ketamine
- An overall improvement in the clinical condition of the patient by the practitioner
- Creation of a biological collection for future ancillary studies dedicated to genetic analysis (microRNA and mRNA).
- The efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS self-report questionnaire, in patients hospitalized for suicide risk.
- Conditions
- Suicidal Ideation
- Being tested
- Baseline evaluation, 1st perfusion of ketamine, 1st perfusion of saline, Follow-up between perfusions, 2nd perfusion of ketamine
- Keywords
- treatment of acute suicidal ideation, ketamine, low-dose ketamine
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline evaluationOther
Before perfusions begin, each patient will have a baseline evaluation including the following: the Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analog scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI-S), Beck's Hopeless scale (BHS), the Inventory of Depressive Symptomatology for the Clinician (IDS-C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS).
1st perfusion of ketamineDrug
A 1st perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 0)
1st perfusion of salineDrug
A 1st perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 0)
Follow-up between perfusionsOther
Patients will be re-evaluated with a selection of questionnaires at 40 minutes, 120 minutes, 4 hours, and 24 hours after the end of the first perfusion, and then again at 48 hours after the end of the first perfusion and right before the second perfusion and then again Day 3, Day 4, Week 2, Week 4 and Week 6.
2nd perfusion of ketamineDrug
A 2nd perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 2)
2nd perfusion of salineDrug
A 2nd perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 2)
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Patients randomized to this group will be treated via Ketamine infusion.
Intervention: Baseline evaluation Intervention: 1st perfusion of ketamine Intervention: Follow-up between perfusions Intervention: 2nd perfusion of ketamine Intervention: Follow-up after perfusions Receives: Other: Baseline evaluation; Drug: 1st perfusion of ketamine; Other: Follow-up between perfusions; Drug: 2nd perfusion of ketamine |
| Placebo/Control | Placebo comparator | Patients randomized to this group will be treated via saline solution infusion.
Intervention: Baseline evaluation Intervention: 1st perfusion of saline Intervention: Follow-up between perfusions Intervention: 2nd perfusion of saline Intervention: Follow-up after perfusions Receives: Other: Baseline evaluation; Drug: 1st perfusion of saline; Other: Follow-up between perfusions; Drug: 2nd perfusion of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSSI score
A suicidal ideation score measured using the BSS (Beck et al. 1979) in its hetero questionnaire form ≤ 3 at 24 hours after the second infusion of ketamine or placebo (yes/no). A threshold ≤ 3 separates the resolution of suicidal ideas from their persistence (Holi et al. 2005; DiazGranados et al. 2010).
Measured: Day 3
Secondary outcomes (89)
The occurrence of a suicide attempt or a completed suicide (yes/no)
Measured: 6 weeks
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Baseline (Day-2 to Day 0)
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Day 1
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Day 2
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Day 3
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Day 4
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Week 2
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Week 4
Evaluation of the full spectrum of suicidality using the CSSRS
Measured: Week 6
The BSSI score
Measured: Baseline (Day-2 to Day 0)
The BSSI score
Measured: 40 min after end of 1st perfusion (Day 0)
The BSSI score
Measured: 120 min after end of 1st perfusion (Day 0)
The BSSI score
Measured: 4 hours after end of 1st perfusion (Day 0)
The BSSI score
Measured: Day 1
The BSSI score
Measured: Day 2
The BSSI score
Measured: Day 4
The BSSI score
Measured: Week 2
The BSSI score
Measured: Week 4
The BSSI score
Measured: Week 6
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Baseline (Day-2 to Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 40 min after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 120 min after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 4 hours after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 1
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 2
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 3
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 4
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 2
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 4
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 6
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Baseline (Day-2 to Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 40 min after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 120 min after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: 4 hours after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 1
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 2
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 3
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Day 4
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 2
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 4
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Measured: Week 6
Evaluation of despair using the Beck Hopelessness Scale
Measured: Baseline (Day-2 to Day 0)
Evaluation of despair using the Beck Hopelessness Scale
Measured: Day 1
Evaluation of despair using the Beck Hopelessness Scale
Measured: Day 2
Evaluation of despair using the Beck Hopelessness Scale
Measured: Day 3
Evaluation of despair using the Beck Hopelessness Scale
Measured: Day 4
Evaluation of despair using the Beck Hopelessness Scale
Measured: Week 2
Evaluation of despair using the Beck Hopelessness Scale
Measured: Week 4
Evaluation of despair using the Beck Hopelessness Scale
Measured: Week 6
Evaluation of depression by the clinician (IDS-C30)
Measured: Baseline (Day-2 to Day 0)
Evaluation of depression by the clinician (IDS-C30)
Measured: 4 hours after end of 1st perfusion (Day 0)
Evaluation of depression by the clinician (IDS-C30)
Measured: Day 1
Evaluation of depression by the clinician (IDS-C30)
Measured: Day 2
Evaluation of depression by the clinician (IDS-C30)
Measured: Day 3
Evaluation of depression by the clinician (IDS-C30)
Measured: Day 4
Evaluation of depression by the clinician (IDS-C30)
Measured: Week 2
Evaluation of depression by the clinician (IDS-C30)
Measured: Week 4
Evaluation of depression by the clinician (IDS-C30)
Measured: Week 6
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Measured: Baseline (Day-2 to Day 0)
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Measured: Day 1
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Measured: Day 2
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Measured: Day 3
Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up
Measured: Day 4
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Measured: Baseline (Day-2 to Day 0)
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Measured: Day 1
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Measured: Day 2
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Measured: Day 3
Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS)
Measured: Day 4
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Measured: Baseline (Day-2 to Day 0)
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Measured: Day 1
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Measured: Day 2
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Measured: Day 3
Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS)
Measured: Day 4
Presence/absence of abnormal monitoring values throughout the study: hypertension
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Measured: 6 weeks
Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Measured: 6 weeks
Presence/absence of abnormal monitoring values throughout the study: cardiac frequency
Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.
Measured: 6 weeks
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Baseline (Day-2 to Day 0)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: 40 min after end of 1st perfusion (Day 0)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: 120 min after end of 1st perfusion (Day 0)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: 4 hours after end of 1st perfusion (Day 0)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Day 1
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Day 2
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: 120 min after end of 2nd perfusion (Day 2)
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Day 3
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Day 4
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Week 2
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Week 4
Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I)
Measured: Week 6
The BSSI score
A suicidal ideation score measured using the BSS (Beck et al. 1979) in its self report questionnaire form ≤ 3 at 24 hours after the second infusion of ketamine or placebo (yes/no). This scale is validated in French (de Man, Balkou \& Iglesias 1987); a threshold ≤ 3 separates the resolution of suicidal ideas from their persistence (Holi et al. 2005; DiazGranados et al. 2010)
Measured: 24 hours after the last perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2015
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mocrane Abbar, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299440
- Sponsor's protocol ID
- PHRC-N/2013/MA-01
- Other IDs
- 2014-001324-30, 2014
- Acronym
- KETIS
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2014
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abbar M, Demattei C, El-Hage W, Llorca PM, Samalin L, Demaricourt P, Gaillard R, Courtet P, Vaiva G, Gorwood P, Fabbro P, Jollant F. Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. BMJ. 2022 Feb 2;376:e067194. doi: 10.1136/bmj-2021-067194.
PubMed 35110300Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT02299440
- Acronym / sponsor ID
- KETIS / PHRC-N/2013/MA-01
- Conditions
- Suicidal Ideation
- Keywords
- treatment of acute suicidal ideation, ketamine, low-dose ketamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 24 Nov 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 primary objective of this study is to assess the efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS hetero questionnaire, in patients hospitalized for suicide risk.
Detailed description
The secondary objectives of this study are to assess:
- The maintenance of medium-term effectiveness of ketamine on the resolution of suicidal ideation
- The evolution of the full spectrum of suicidality under ketamine compared to placebo
- The evolution of psychic and physical pain scores under ketamine compared to placebo
- The evolution of Beck Hopelessness score which is a predictor of long-term suicide risk, under ketamine compared to placebo
- The early antidepressant efficacy of ketamine in depressed, uni- or bipolar patients
- The somatic and psychological tolerance of ketamine
- An overall improvement in the clinical condition of the patient by the practitioner
- Creation of a biological collection for future ancillary studies dedicated to genetic analysis (microRNA and mRNA).
- The efficacy of ketamine versus a placebo for the short-term (at 72h, i.e. 24h after the last perfusion) relief of suicidal ideation, measured using the BSS self-report questionnaire, in patients hospitalized for suicide risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Other: Baseline evaluation, Drug: 1st perfusion of ketamine, Other: Follow-up between perfusions, Drug: 2nd perfusion of ketaminePatients randomized to this group will be treated via Ketamine infusion. Intervention: Baseline evaluation Intervention: 1st perfusion of ketamine Intervention: Follow-up between perfusions Intervention: 2nd perfusion of ketamine Intervention: Follow-up after perfusions |
| Placebo/Control | Placebo comparator | Other: Baseline evaluation, Drug: 1st perfusion of saline, Other: Follow-up between perfusions, Drug: 2nd perfusion of salinePatients randomized to this group will be treated via saline solution infusion. Intervention: Baseline evaluation Intervention: 1st perfusion of saline Intervention: Follow-up between perfusions Intervention: 2nd perfusion of saline Intervention: Follow-up after perfusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- French speaking patients freely hospitalized for prevention of suicide and who have a medium or high suicide risk score according to a MINI structured interview
- The patient is able to understand how the study is carried out and the tests performed
- The patient is deemed capable of giving his/her informed consent
- The patient has been correctly informed
- The patient must have given his/her informed and signed consent.
Key exclusion criteria (18 listed)
- The patient is participating in another interventional study
- Within the past three months, the patient has participated in another interventional study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
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 |
|---|---|---|
| Baseline evaluationBefore perfusions begin, each patient will have a baseline evaluation including the following: the Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analog scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI-S), Beck's Hopeless scale (BHS), the Inventory of Depressive Symptomatology for the Clinician (IDS-C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS). | Other | Ketamine, Placebo/Control |
| 1st perfusion of ketamineA 1st perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 0) | Drug | Ketamine |
| 1st perfusion of salineA 1st perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 0) | Drug | Placebo/Control |
| Follow-up between perfusionsPatients will be re-evaluated with a selection of questionnaires at 40 minutes, 120 minutes, 4 hours, and 24 hours after the end of the first perfusion, and then again at 48 hours after the end of the first perfusion and right before the second perfusion and then again Day 3, Day 4, Week 2, Week 4 and Week 6. | Other | Ketamine, Placebo/Control |
| 2nd perfusion of ketamineA 2nd perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 2) | Drug | Ketamine |
| 2nd perfusion of salineA 2nd perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 2) | Drug | Placebo/Control |
Primary outcome
BSSI score
Time frame: Day 3
A suicidal ideation score measured using the BSS (Beck et al. 1979) in its hetero questionnaire form ≤ 3 at 24 hours after the second infusion of ketamine or placebo (yes/no). A threshold ≤ 3 separates the resolution of suicidal ideas from their persistence (Holi et al. 2005; DiazGranados et al. 2010).
89 secondary outcomes
The occurrence of a suicide attempt or a completed suicide (yes/no)
Time frame: 6 weeks
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Baseline (Day-2 to Day 0)
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Day 1
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Day 2
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Day 3
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Day 4
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Week 2
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Week 4
Evaluation of the full spectrum of suicidality using the CSSRS
Time frame: Week 6
The BSSI score
Time frame: Baseline (Day-2 to Day 0)
The BSSI score
Time frame: 40 min after end of 1st perfusion (Day 0)
The BSSI score
Time frame: 120 min after end of 1st perfusion (Day 0)
The BSSI score
Time frame: 4 hours after end of 1st perfusion (Day 0)
The BSSI score
Time frame: Day 1
The BSSI score
Time frame: Day 2
The BSSI score
Time frame: Day 4
The BSSI score
Time frame: Week 2
The BSSI score
Time frame: Week 4
The BSSI score
Time frame: Week 6
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Baseline (Day-2 to Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 40 min after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 120 min after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 4 hours after end of 1st perfusion (Day 0)
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 1
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 2
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 3
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 4
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Week 2
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Week 4
Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Week 6
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Baseline (Day-2 to Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 40 min after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 120 min after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: 4 hours after end of 1st perfusion (Day 0)
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 1
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 2
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 3
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Day 4
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Week 2
Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 35110300Abbar M, Demattei C, El-Hage W, Llorca PM, Samalin L, Demaricourt P, Gaillard R, Courtet P, Vaiva G, Gorwood P, Fabbro P, Jollant F. Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. BMJ. 2022 Feb 2;376:e067194. doi: 10.1136/bmj-2021-067194.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- 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.
Mocrane Abbar, MD study director
Centre Hospitalier Universitaire de Nīmes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baseline evaluation, 1st perfusion of ketamine and 1st perfusion of saline in people with Suicidal Ideation, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BSSI score (time frame: Day 3). 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 NCT02299440, which also lists 2 linked publications.
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 1 Dec 2025.