Clinical TrialSuicidalityKetaminePlaceboPlaceboKetamineWithdrawn

Intramuscular Ketamine for Suicidal Ideation

This crossover, subject-blinded, clinical trial (n=0, withdrawn) aimed to correlate changes in brain activity with the reduction in suicidal ideation (SI) in response to a single intramuscular dose of ketamine.

Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

A randomised, double-blind, crossover pilot study planned to test whether specific EEG changes correlate with reduction in suicidal ideation following a single IM ketamine dose (0.5 mg/kg) compared with placebo in inpatients with clinically significant SI.

Primary aims were to identify EEG biomarkers associated with anti-suicidal response and to assess the acute effectiveness of IM ketamine on suicidal ideation; outcomes included EEG measures and standard clinical scales (MADRS item 10, C-SSRS).

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine then Placebo

experimental

Participants receive IM ketamine on day 1 then IM placebo on day 2 (crossover).

Interventions

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

    Racemic ketamine (Ketalar) 0.5 mg/kg IM, single-session; crossover with next-day placebo.

  • Placebo
    via IM• single dose• 1 doses total

    Matching IM saline placebo administered on day 2.

Placebo then Ketamine

inactive

Participants receive IM placebo on day 1 then IM ketamine on day 2 (crossover).

Interventions

  • Placebo
    via IM• single dose• 1 doses total

    Matching IM saline placebo administered on day 1.

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

    Racemic ketamine (Ketalar) 0.5 mg/kg IM on day 2.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
  • Inpatient status at the time of study initiation.
  • 18 to 70 years of age
  • Capacity to consent

Exclusion Criteria

  • Exclusion criteria:
  • Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
  • Diagnosis of pervasive developmental disorder
  • Diagnosis of a major neurocognitive disorder
  • A positive urine pregnancy test
  • Currently breastfeeding
  • Drug or alcohol abuse or dependence within the preceding 3 months
  • Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
  • Medical issues or laboratory abnormalities requiring acute intervention
  • Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
  • Any lifetime history of ketamine or phencyclidine abuse
  • A known hypersensitivity to or history of a serious adverse effect from to ketamine

Study Details

Locations

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

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