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Completed

NCT Number: NCT02299440

Effects of Ketamine in the Acute Phase of Suicidal Ideation

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline evaluation

Other

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 ketamine

Drug

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 saline

Drug

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 perfusions

Other

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 ketamine

Drug

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 saline

Drug

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)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Evaluation of the Effects of Ketamine in the Acute Phase of Suicidal Ideation: a Multicenter Randomized Double-blind Trial

Acronym: KETIS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2014
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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