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CompletedPhase 3Results posted

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

NCT03539887 · The University of Texas Health Science Center, Houston

Closed to entry
Status
Not accepting participants
Phase 3
Phase
33
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over 24 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 60 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
The University of Texas Health Science Center at HoustonHoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03539887 on ClinicalTrials.gov →

Last updated in the registry 2023-03-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits