Phase 3
Completed N=28
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Suicidal Ideation · Depression · Alcohol Abuse
Source: ClinicalTrials.gov NCT03539887 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) — 10.8; 12.3 score on a scale
◆ Published Evidence
Emerging
13citations · ~7 / year
A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of the Acute Antisuicidal and Antidepressant Effects of Intranasal (R,S)-Ketamine in Severe Unipolar and Bipolar Depression With and Without Comorbid Alcohol Use Disorder.
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.
Linked Publications
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A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of the Acute Antisuicidal and Antidepressant Effects of Intranasal (R,S)-Ketamine in Severe Unipolar and Bipolar Depression With and Without Comorbid Alcohol Use Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) |
10.8; 12.3 | — |
| SECONDARY Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) |
16.8; 22.5 | — |
| SECONDARY Snaith-Hamilton Pleasure Scale |
4.12; 5.00 | — |
| SECONDARY Alcohol Urge Questionnaire (AUQ) |
13.8; 16.3 | — |
| SECONDARY Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS) |
2.29; 2.40 | — |
| SECONDARY Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS) |
0.824; 1.60 | — |
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
Data sourced from ClinicalTrials.gov (NCT03539887) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.