Clinical TrialSuicidalityKetaminePlaceboCompleted

Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.

Target Enrollment
33 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

Clinicians have a limited ability to predict imminent suicidal behaviour and efficacious treatments are not available to treat suicidal patients; rapid-acting treatments are therefore needed. This study tests whether a single intranasal dose of ketamine produces rapid and sustained reductions in suicidal ideation and depressive symptoms in inpatients with MDD or BD, with or without recent alcohol abuse.

Outcomes include measures of suicidal ideation, depressive symptoms, and exploration of mediators or moderators of response; results may have substantial public-health implications if intranasal ketamine demonstrates antisuicidal efficacy.

Study Protocol

Preparation

sessions

Dosing

1 sessions
15 min each

Integration

sessions

Study Arms & Interventions

Intranasal ketamine

experimental

Intranasal ketamine, 50 mg total (5×10 mg applications) delivered over 15 minutes; single dose.

Interventions

  • Ketamine50 mg
    via Other• single dose• 1 doses total

    5 intranasal applications (100 μl each) over 15 minutes; dose range reported 0.5–1 mg/kg

Placebo

inactive

Intranasal saline placebo (5 applications)

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Saline; 5 intranasal applications (100 μl each) over 15 minutes

Participants

Ages
21 – 60
Sexes
Male & Female

Inclusion Criteria

  • Voluntary admission to Harris County Psychiatry Center
  • Able to provide written informed consent
  • Current suicidal ideation and depressive symptoms and Diagnostic and Statistical Manual of Mental Disorders -IV- Text Revision (DSM-IV-TR) depressive episode (also MADRS greater than or equal to 12) and Young Mania Rating Scale (YMRS) score lower than 8
  • DSM-IV-TR criteria for current alcohol abuse (but not intoxicated/withdrawal, abstinent from drinking for > 5 days prior to admission)
  • Lifetime history of suicide attempt (patient)
  • Not taking any medication in the last 24hs.
  • Scale for Suicide Ideation (SSI) score over 4 (first five items) and Columbia scale (C-SSRS) score 4 or 5

Exclusion Criteria

  • Unstable medical condition or medical problem with known central nervous system (CNS) effects, e.g. uncontrolled hypertension (systolic blood pressure (SBP) ≥170 and/or diastolic blood pressure (DBP) ≥100) or recent history (6 months) of alcohol-withdrawal seizures or significant abnormal laboratory tests (liver function test (LFT) 3 times higher than normal).
  • Prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, psychotic symptoms, or personality disorder.
  • Currently under the acute effects of an illicit substance.
  • Pregnant or nursing women.
  • Subjects with a history of DSM-IV drug dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment33 participants
  • Timeline
    Start: 2008-05-01
    End: 2022-12-25
  • Compounds
    KetaminePlacebo
  • Topic
    Suicidality

Locations

The University of Texas Health Science Center at Houston — Houston, Texas, United States

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