Clinical TrialSuicidalityKetaminePlaceboCompleted

Ketamine For Suicidal Ideation

Randomised, quadruple-blind, parallel-arm trial (n=24) testing a single IV ketamine infusion (0.5 mg/kg, 40 min) versus midazolam (0.45 mg/kg, 40 min) for rapid reduction of suicidal ideation in adults hospitalized or presenting with SI.

Target Enrollment
24 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, parallel-arm, quadruple-blind study compared a single sub-anesthetic IV dose of ketamine (0.5 mg/kg) to an active anesthetic control (midazolam 0.45 mg/kg), each infused over 40 minutes, in adults with clinically significant suicidal ideation.

Primary aims were feasibility, tolerability, and rapid anti-suicidal efficacy, with outcomes assessed acutely and within 24 hours; participants continued standard psychiatric treatment throughout the trial.

The trial enrolled 24 participants aged 18–80 at Icahn School of Medicine at Mount Sinai; midazolam was chosen to preserve blinding by producing transient subjective effects without expected sustained antidepressant benefit.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg over 40 minutes.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes.

Midazolam

active comparator

Single IV infusion of midazolam 0.45 mg/kg over 40 minutes (anesthetic control).

Interventions

  • Placebo0.45 mg/kg
    via IV• single dose• 1 doses total

    Midazolam 0.45 mg/kg infused over 40 minutes (anesthetic control; named in notes).

Participants

Ages
18 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • English speaking Male or female patients, 18-80 years
  • Patients have voluntarily admitted themselves to an inpatient psychiatric unit at MSH or, regarding the outpatient population, have clinically significant suicidal ideation without intent to harm themselves
  • Women of childbearing potential must have a negative pregnancy test
  • Clinically significant suicidal ideation and score of ≥4 on MADRS item 10 for suicidality
  • Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

Exclusion Criteria

  • Exclusion Criteria:
  • Lifetime history of schizophrenia or other primary psychotic disorder
  • Current presence of psychotic symptoms
  • Lifetime history of a clearly established psychotic episode
  • Established diagnosis of Schizoid, Schizotypal or Paranoid personality disorder
  • Urine toxicology screen positive for drugs of abuse on admission
  • Substance abuse or dependence within the preceding 1 month
  • Anticipated discharge within 7 days of study enrollment (for patients in the inpatient arm)
  • Women who plan to become pregnant, are pregnant or are breast-feeding
  • Concurrent course of electroconvulsive therapy (ECT)
  • Any unstable medical illness including hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
  • Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
  • The presence of any known or suspected contraindications to midazolam or ketamine including, but not limited to, known allergic reactions to these agents or acute intermittent porphyria
  • Uncontrolled hypertension, defined as BP systolic >160 or BP diastolic >100 on medications
  • Arrhythmia requiring medication
  • Severe coronary artery disease, defined as Canadian Cardiovascular Status III or IV

Study Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2012-01-01
    End: 2014-01-09
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

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