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Effects of Ketamine in the Acute Phase of Suicidal Ideation (KETIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02299440
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Other: Baseline evaluation Drug: 1st perfusion of ketamine Drug: 1st perfusion of saline Other: Follow-up between perfusions Drug: 2nd perfusion of ketamine Drug: 2nd perfusion of saline Phase 3

Detailed Description:

The secondary objectives of this study are to assess:

A. The maintenance of medium-term effectiveness of ketamine on the resolution of suicidal ideation

B. The evolution of the full spectrum of suicidality under ketamine compared to placebo

C. The evolution of psychic and physical pain scores under ketamine compared to placebo

D. The evolution of Beck Hopelessness score which is a predictor of long-term suicide risk, under ketamine compared to placebo

E. The early antidepressant efficacy of ketamine in depressed, uni- or bipolar patients

F. The somatic and psychological tolerance of ketamine

G. An overall improvement in the clinical condition of the patient by the practitioner

H. Creation of a biological collection for future ancillary studies dedicated to genetic analysis (microRNA and mRNA).

I. 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial
Actual Study Start Date : April 2015
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine

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

 Other: Baseline evaluation
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).

Drug: 1st perfusion of ketamine
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)

Other: Follow-up between perfusions
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.

Drug: 2nd perfusion of ketamine
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)
Placebo Comparator: Placebo/Control

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

 Other: Baseline evaluation
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).

Drug: 1st perfusion of saline
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)

Other: Follow-up between perfusions
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.

Drug: 2nd perfusion of saline
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The occurrence of a suicide attempt or a completed suicide (yes/no) [ Time Frame: 6 weeks ]
  2. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Baseline (Day-2 to Day 0) ]
  3. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 1 ]
  4. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 2 ]
  5. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 3 ]
  6. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Day 4 ]
  7. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 2 ]
  8. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 4 ]
  9. Evaluation of the full spectrum of suicidality using the CSSRS [ Time Frame: Week 6 ]
  10. The BSSI score [ Time Frame: Baseline (Day-2 to Day 0) ]
  11. The BSSI score [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  12. The BSSI score [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  13. The BSSI score [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  14. The BSSI score [ Time Frame: Day 1 ]
  15. The BSSI score [ Time Frame: Day 2 ]
  16. The BSSI score [ Time Frame: Day 4 ]
  17. The BSSI score [ Time Frame: Week 2 ]
  18. The BSSI score [ Time Frame: Week 4 ]
  19. The BSSI score [ Time Frame: Week 6 ]
  20. 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) ]
  21. 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) ]
  22. 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) ]
  23. 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) ]
  24. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  25. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  26. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  27. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  28. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  29. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  30. Evaluation of physical pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  31. 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) ]
  32. 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) ]
  33. 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) ]
  34. 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) ]
  35. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 1 ]
  36. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 2 ]
  37. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 3 ]
  38. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Day 4 ]
  39. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 2 ]
  40. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 4 ]
  41. Evaluation of mental pain using a visual analog scale of 0 to 10 following a Lickert model [ Time Frame: Week 6 ]
  42. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Baseline (Day-2 to Day 0) ]
  43. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 1 ]
  44. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 2 ]
  45. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 3 ]
  46. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Day 4 ]
  47. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 2 ]
  48. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 4 ]
  49. Evaluation of despair using the Beck Hopelessness Scale [ Time Frame: Week 6 ]
  50. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Baseline (Day-2 to Day 0) ]
  51. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  52. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 1 ]
  53. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 2 ]
  54. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 3 ]
  55. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Day 4 ]
  56. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 2 ]
  57. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 4 ]
  58. Evaluation of depression by the clinician (IDS-C30) [ Time Frame: Week 6 ]
  59. Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Baseline (Day-2 to Day 0) ]
  60. Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 1 ]
  61. Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 2 ]
  62. Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 3 ]
  63. Evaluation of somatic tolerance of ketamine using the Patient Rated Inventory of Side Effects (PRISE) throughout follow-up [ Time Frame: Day 4 ]
  64. Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  65. Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 1 ]
  66. Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 2 ]
  67. Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 3 ]
  68. Evaluation of psychic tolerance using the Young Mania Rating Scale (YMRS) [ Time Frame: Day 4 ]
  69. Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline (Day-2 to Day 0) ]
  70. Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 1 ]
  71. Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 2 ]
  72. Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 3 ]
  73. Evaluation of psychic tolerance using the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Day 4 ]
  74. Presence/absence of abnormal monitoring values throughout the study: hypertension [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.

  75. Presence/absence of abnormal monitoring values throughout the study: pulse oxymetry [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.

  76. Presence/absence of abnormal monitoring values throughout the study: cardiac frequency [ Time Frame: 6 weeks ]
    Any abnormal hypertension, pulse oxymetry or cardiac frequency values observed during the study will be noted.

  77. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Baseline (Day-2 to Day 0) ]
  78. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 40 min after end of 1st perfusion (Day 0) ]
  79. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 1st perfusion (Day 0) ]
  80. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 4 hours after end of 1st perfusion (Day 0) ]
  81. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 1 ]
  82. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 2 ]
  83. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: 120 min after end of 2nd perfusion (Day 2) ]
  84. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 3 ]
  85. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Day 4 ]
  86. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 2 ]
  87. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 4 ]
  88. Evaluation of the improvement of the patient's clinical condition using the Clinical Global Impression scale - Improvement (CGI-I) [ Time Frame: Week 6 ]
  89. The BSSI score [ Time Frame: 24 hours after the last perfusion ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299440


Locations
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France
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont Ferrand, France, 63003
CHRU de Lille - Hôpital Michel Fontan
Lille, France, 59037
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Clinique Les Sophoras
Nîmes, France, 30000
Centre Hospitalier Sainte-Anne
Paris cedex 14, France, 75674
APHP - Hôpital Lariboisière
Paris, France, 75010
CMME Centre Hospitalier Sainte Anne
Paris, France, 75674
CHRU de Tours - Clinique Psychiatrique Universitaire
Saint Cyr sur Loire, France, 37540
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Mocrane Abbar, MD Centre Hospitalier Universitaire de Nîmes
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02299440    
Other Study ID Numbers: PHRC-N/2013/MA-01
2014-001324-30 ( EudraCT Number )
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
treatment of acute suicidal ideation
ketamine
low-dose ketamine
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action