Back to resultsTrial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Primary Purpose
Suicidal Ideation, Depression, Alcohol Abuse
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intranasal ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Ketamine, Depression, Suicidal Ideation, Alcohol Abuse
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.
- 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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intranasal ketamine
Placebo
Arm Description
Intranasal ketamine
non-active placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
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.
Snaith-Hamilton Pleasure Scale
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.
Alcohol Urge Questionnaire (AUQ)
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.
Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)
The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania.
Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)
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.
Full Information
NCT ID
NCT03539887
First Posted
May 16, 2018
Last Updated
February 27, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03539887
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Depression, Alcohol Abuse
Keywords
Ketamine, Depression, Suicidal Ideation, Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal ketamine
Arm Type
Experimental
Arm Description
Intranasal ketamine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
non-active placebo
Intervention Type
Drug
Intervention Name(s)
Intranasal ketamine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
24 hours
Title
Snaith-Hamilton Pleasure Scale
Description
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.
Time Frame
24 hours
Title
Alcohol Urge Questionnaire (AUQ)
Description
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.
Time Frame
24 hours
Title
Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)
Description
The YMRS has 11 items, and total score ranges from 0 to 88, with a higher score indicating greater mania.
Time Frame
24 hours
Title
Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Machado-Vieira, MD, PhD, MSc
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
12. IPD Sharing Statement
Links:
URL
https://med.uth.edu/psychiatry/faculty/rodrigo-machado-vieira-m-d-ph-d-m-sc/
Description
Department of Psychiatry, Dr Rodrigo Machado-Vieira
URL
https://med.uth.edu/psychiatry/research/programs/experimental-therapeutics-molecular-pathophysiology-program/
Description
Experimental Therapeutics and Molecular Pathophysiology, UTHealth, Houston, Texas
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Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
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