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

NCT03539887 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: HSC-MS-17-0903
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Suicidal Ideation; Depression; Alcohol Abuse

Keywords

Ketamine; Depression; Suicidal Ideation; Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)

  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.

  24 hours

Secondary Outcomes (5)

• Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)

  24 hours

• Snaith-Hamilton Pleasure Scale

  24 hours

• Alcohol Urge Questionnaire (AUQ)

  24 hours

• Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)

  24 hours

• Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)

  24 hours

Study Arms (2)

Intranasal ketamine

EXPERIMENTAL

Intranasal ketamine

Drug: Intranasal ketamine

Placebo

PLACEBO COMPARATOR

non-active placebo

Drug: Placebo

Interventions

Intranasal ketamine DRUG

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).

Intranasal ketamine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

Location

Related Publications (1)

• Jones GH, Vecera CM, Ruiz AC, Wu HE, McInturff SI, Orejarena MJ, Smith KA, Soares JC, Zarate CA, Lane SD, Machado-Vieira R. 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. J Clin Psychiatry. 2024 Apr 24;85(2):23m14974. doi: 10.4088/JCP.23m14974.

  PMID: 38696221 DERIVED

Related Links

• Department of Psychiatry, Dr Rodrigo Machado-Vieira
• Experimental Therapeutics and Molecular Pathophysiology, UTHealth, Houston, Texas

MeSH Terms

Conditions

Suicidal Ideation; Depression; Alcoholism

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Rodrigo Machado-Vieira, MD, PhD, MSc
• Organization: The University of Texas Health Science Center at Houston

Rodrigo.MachadoVieira@uth.tmc.edu

(713) 741-5000

Study Officials

• Rodrigo Machado-Vieira, MD, PhD, MSc

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 1, 2018
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Locations

US (1)