Intranasal Ketamine for Suicidal Ideation in Veterans
Primary Purpose
Suicidal Ideation
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring Ketamine, Veteran, Suicide, Suicidal Ideation
Eligibility Criteria
Inclusion Criteria:
- Male or female patients, 21-70 years of age
- Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration
- Any non-psychotic disorder diagnosis
- Score >4 on the suicide item of the Montgomery-Asberg Depression Rating Scale (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide attempts
- Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
- Each participant must agree to avoid future enrollment in ketamine trials.
Exclusion Criteria:
- current psychotic symptoms or lifetime history of primary psychotic disorder
- active substance use in the preceding two weeks or needing medical attention for withdrawal
- neurodevelopmental disorder (e.g., ASD)
- major neurocognitive disorder (e.g., Alzheimer's type dementia)
- serious cardiac disease
- suicide attempt precipitating current admission requiring medical stabilization
- Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
- Women who are either pregnant or nursing
- Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with study drug
- Previously received ketamine for refractory depression.
Sites / Locations
- James J. Peters VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intranasal Ketamine
Arm Description
Subjects will receive study medication, intranasal ketamine.
Outcomes
Primary Outcome Measures
Change in Beck Scale for Suicidal Ideation (BSSI)
Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Secondary Outcome Measures
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)
QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.
Full Information
NCT ID
NCT03788694
First Posted
December 26, 2018
Last Updated
August 3, 2023
Sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborators
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03788694
Brief Title
Intranasal Ketamine for Suicidal Ideation in Veterans
Official Title
Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never funded nor started, no participants were enrolled
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborators
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.
Detailed Description
To address the significant need for effective treatment of suicidal ideation in Veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Ketamine, Veteran, Suicide, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Ketamine
Arm Type
Experimental
Arm Description
Subjects will receive study medication, intranasal ketamine.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
8 doses of intranasal ketamine; 40 mg per dose.
Primary Outcome Measure Information:
Title
Change in Beck Scale for Suicidal Ideation (BSSI)
Description
Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Time Frame
Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Time Frame
Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
Title
The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)
Description
QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.
Time Frame
Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients, 21-70 years of age
Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration
Any non-psychotic disorder diagnosis
Score >4 on the suicide item of the Montgomery-Asberg Depression Rating Scale (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide attempts
Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
Each participant must agree to avoid future enrollment in ketamine trials.
Exclusion Criteria:
current psychotic symptoms or lifetime history of primary psychotic disorder
active substance use in the preceding two weeks or needing medical attention for withdrawal
neurodevelopmental disorder (e.g., ASD)
major neurocognitive disorder (e.g., Alzheimer's type dementia)
serious cardiac disease
suicide attempt precipitating current admission requiring medical stabilization
Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
Women who are either pregnant or nursing
Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) at screening or immediately prior to treatment with study drug
Previously received ketamine for refractory depression.
Facility Information:
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.
IPD Sharing Time Frame
6 months after publication and will remain available for 5 years.
Learn more about this trial
Intranasal Ketamine for Suicidal Ideation in Veterans
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