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

Clinicians have a limited ability to predict imminent suicidal behavior and efficacious
treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for
suicidal individuals are truly needed. 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. These results will elucidate the
antisuicidal effects of ketamine using the intranasal route along with the identification of
associated mediators or moderators; this approach has the potential for enormous public
health impact.

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.

- 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
diasotlic 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