Clinical trial NCT03539887: Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Suicidal Ideation
Depression
Alcohol Abuse
Keywords: Ketamine
Depression
Suicidal Ideation
Alcohol Abuse
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled
Primary purpose: TREATMENT

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.

Detailed description: 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.

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

Primary outcomes:
measure: Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
timeFrame: 24 hours
Secondary outcomes:
measure: Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 24 hours
measure: Snaith-Hamilton Pleasure Scale
timeFrame: 24 hours
measure: Alcohol Urge Questionnaire (AUQ)
timeFrame: 24 hours
measure: Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)
timeFrame: 24 hours
measure: Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Rodrigo Machado-Vieira, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: