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

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ClinicalTrials.gov Identifier: NCT03539887
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Rodrigo Machado-Vieira, MD, PhD, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Suicidal ideation as assessed by the Scale for Suicide Ideation (SSI) [ Time Frame: 24 hours ]
  • Suicidal ideation as assessed by the Scale for Suicide Ideation (SSI) [ Time Frame: 48 hours ]
  • Suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours ]
  • Suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 48 hours ]
  • Suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours ]
  • Suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 48 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • 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.
  • Snaith-Hamilton Pleasure Scale [ Time Frame: 4 and 24 hours ]
    The Snaith-Hamilton Pleasure Scale (SHAPS) is an assessment of anhedonia, which has been extensively used by our group. The 14-item measure takes 5 minutes to complete (Snaith et al 1995).
  • Alcohol Urge Questionnaire (AUQ) [ Time Frame: 4 and 24hs ]
    Alcohol Urge Questionnaire (AUQ) is a multi-item measure of self- reported urges to drink alcohol, predictor of drinking abuse and relapse (Bohn MJ, Krahn DD, Staehler BA 1995) and AUDIT/CIWA.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
  • Depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 48 hours ]
  • Recent alcohol abuse as assessed by the Alcohol Urge Questionnaire (AUQ) [ Time Frame: baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Suicidal Ideation
  • Depression
  • Alcohol Abuse
Intervention  ICMJE
  • Drug: Intranasal ketamine
    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).
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Experimental: Intranasal ketamine
    Intranasal ketamine
    Intervention: Drug: Intranasal ketamine
  • Experimental: Intranasal ketamine in alcohol abuse
    Intranasal ketamine
    Intervention: Drug: Intranasal ketamine
  • Placebo Comparator: Placebo
    non-active placebo
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo in alcohol abuse
    non-active placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2018)
45
Estimated Study Completion Date  ICMJE December 25, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rodrigo Machado-Vieira, MD, PhD, MSc (713) 741-6047 Rodrigo.MachadoVieira@uth.tmc.edu
Contact: Sarah H Hernandez 713-741-6087 Sarah.K.Hernandez@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539887
Other Study ID Numbers  ICMJE HSC-MS-17-0903
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodrigo Machado-Vieira, MD, PhD, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP