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Completed

NCT Number: NCT03539887

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

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.

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Key information

Conditions

Suicidal Ideation Alcohol Abuse Alcohol-Related Disorders Alcoholism Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Self-Injurious Behavior Substance-Related Disorders Suicide

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Snaith-Hamilton Pleasure Scale

    Time frame: 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.

  3. Alcohol Urge Questionnaire (AUQ)

    Time frame: 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.

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

    Time frame: 24 hours

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 29, 2018
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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