NCT03539887

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

Completed Phase 3 Results posted Last updated 1 March 2023

What this trial tests

Phase 3 trial testing Intranasal ketamine in Suicidal Ideation in 33 participants. Completed in 15 January 2022.

Timeline

1 May 2018

Primary endpoint
15 January 2022

15 January 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	33
Start date	1 May 2018
Primary completion	15 January 2022
Estimated completion	15 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Intranasal ketamine — full drug profile →
• Placebo

Conditions studied

• Suicidal Ideation — all drugs for Suicidal Ideation →
• Depression — all drugs for Depression →
• Alcohol Abuse — all drugs for Alcohol Abuse →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 21 to 60, any sex, with Suicidal Ideation or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI) Primary · 24 hours

The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation.

Group	Value	95% CI
Intranasal Ketamine	10.8	± 8.08
Placebo	12.3	± 7.83

Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) Secondary · 24 hours

It has ten items, each item yields a score of 0 to 6. Hence the overall score ranges from 0 to 60. Higher scores indicate more severe depression.

Group	Value	95% CI
Intranasal Ketamine	16.8	± 13.7
Placebo	22.5	± 17.7

Snaith-Hamilton Pleasure Scale Secondary · 24 hours

The Snaith-Hamilton Pleasure Scale (SHAPS) is an assessment of anhedonia, which is the inability to experience pleasure. The SHAPS has 14 items. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. A response of "strongly disagree" or "disagree" equals one point, and a response of "strongly agree" or "agree" equals 0 points. Thus, the final score ranges from 0 to 14. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more.

Group	Value	95% CI
Intranasal Ketamine	4.12	± 4.81
Placebo	5.00	± 4.29

Alcohol Urge Questionnaire (AUQ) Secondary · 24 hours

Alcohol Urge Questionnaire (AUQ) is a multi-item measure of self-reported urges to drink alcohol, predictor of drinking abuse and relapse. AUQ is an 8-item questionnaire. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. Total score ranges from 8 to 56, and a higher score reflects greater craving.

Group	Value	95% CI
Intranasal Ketamine	13.8	± 12.2
Placebo	16.3	± 11.2

Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS) Secondary · 24 hours

The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania.

Group	Value	95% CI
Intranasal Ketamine	2.29	± 2.85
Placebo	2.40	± 2.12

Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS) Secondary · 24 hours

The CADSS consists of 23 items, and each item is rated on a scale from 0 (not at all) to 4 (severe), with the total score ranging from 0 to 92. A higher score indicates greater severity of dissociative state.

Group	Value	95% CI
Intranasal Ketamine	0.824	± 2.90
Placebo	1.60	± 3.20

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intranasal Ketamine

Serious: 0/17 (0%)

Deaths: 0/17

Placebo

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (1 terms — click to expand)

Reaction	System	Intranasal Ketamine	Placebo
Cognitive side effect	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03539887 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ketamine for the treatment of major depression: a systematic review and meta-analysis.
   Nikolin S, Rodgers A, Schwaab A, Bahji A, et al · · 2023 · cited 85× · PMID 37593223 · DOI 10.1016/j.eclinm.2023.102127
2. 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.
   Jones GH, Vecera CM, Ruiz AC, Wu HE, et al · · 2024 · cited 6× · PMID 38696221 · DOI 10.4088/jcp.23m14974