Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Condition: Suicidal Ideation; Depression; Alcohol Abuse
MeSH terms: Alcoholism; Depression; Depressive Disorder; Suicidal Ideation
Intervention: Intranasal ketamine; Placebo
Intervention description: Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).; Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Ketamine; Depression; Suicidal Ideation; Alcohol Abuse

Summary:

      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.
    

Eligibility criteria:

        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