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Trial record 3 of 7 for:    Ketamine | Recruiting, Active, not recruiting Studies | alcohol

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 : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Rodrigo Machado-Vieira, MD, PhD, MSc, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Depression Alcohol Abuse Drug: Intranasal ketamine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Intranasal ketamine
Intranasal ketamine
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).

Experimental: Intranasal ketamine in alcohol abuse
Intranasal ketamine
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).

Placebo Comparator: Placebo
non-active placebo
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.

Placebo Comparator: Placebo in alcohol abuse
non-active placebo
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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: 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).

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539887


Contacts
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Contact: Rodrigo Machado-Vieira, MD, PhD, MSc (713) 741-5000 Rodrigo.MachadoVieira@uth.tmc.edu
Contact: Courtney Vecera (713) 741-6043 Courtney.Vecera@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77006
Contact: Rodrigo Machado-Vieira, MD PhD MSc(713) 741-3830    (713) 741-3830    Rodrigo.MachadoVieira@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc The University of Texas Health Science Center, Houston
Additional Information:
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Responsible Party: Rodrigo Machado-Vieira, MD, PhD, MSc, Professor of Psychiatry, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03539887    
Other Study ID Numbers: HSC-MS-17-0903
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021

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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
Keywords provided by Rodrigo Machado-Vieira, MD, PhD, MSc, The University of Texas Health Science Center, Houston:
Ketamine
Depression
Suicidal Ideation
Alcohol Abuse
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Ketamine
Alcoholism
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Suicide
Self-Injurious Behavior
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action