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.
Intranasal Ketamine for Suicidal Ideation in Veterans
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.
Condition or Disease
- Suicidal Ideation
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Withdrawn |
| Study results: | No Results Available |
| Age: | 21 Years to 70 Years |
| Enrollment: | 0 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Jan 01, 2020 | ACTUAL |
|---|---|---|
| Primary Completion: | Jan 31, 2020 | ACTUAL |
| Completion Date: | Apr 30, 2020 | ACTUAL |
| Study First Posted: | Dec 27, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Aug 03, 2023 |
Sponsors / Collaborators
Lead Sponsor:
Bronx Veterans Medical Research Foundation, Inc
Responsible Party:
N/A
Location
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.
Participant Groups
-
Subjects will receive study medication, intranasal ketamine.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 21 |
| Maximum Age: | 70 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Male or female patients, 21-70 years of age
2. 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
3. Any non-psychotic disorder diagnosis
4. 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
5. 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
6. Each participant must agree to avoid future enrollment in ketamine trials.
Exclusion Criteria:
1. current psychotic symptoms or lifetime history of primary psychotic disorder
2. active substance use in the preceding two weeks or needing medical attention for withdrawal
3. neurodevelopmental disorder (e.g., ASD)
4. major neurocognitive disorder (e.g., Alzheimer's type dementia)
5. serious cardiac disease
6. suicide attempt precipitating current admission requiring medical stabilization
7. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
8. Women who are either pregnant or nursing
9. Hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg) at screening or immediately prior to treatment with study drug
10. Previously received ketamine for refractory depression.
1. Male or female patients, 21-70 years of age
2. 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
3. Any non-psychotic disorder diagnosis
4. 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
5. 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
6. Each participant must agree to avoid future enrollment in ketamine trials.
Exclusion Criteria:
1. current psychotic symptoms or lifetime history of primary psychotic disorder
2. active substance use in the preceding two weeks or needing medical attention for withdrawal
3. neurodevelopmental disorder (e.g., ASD)
4. major neurocognitive disorder (e.g., Alzheimer's type dementia)
5. serious cardiac disease
6. suicide attempt precipitating current admission requiring medical stabilization
7. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome
8. Women who are either pregnant or nursing
9. Hypertension (systolic BP \>160 mm Hg or diastolic BP \>90 mm Hg) at screening or immediately prior to treatment with study drug
10. Previously received ketamine for refractory depression.
Primary Outcomes
Secondary Outcomes
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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.
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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.
More Details
| NCT Number: | NCT03788694 |
|---|---|
| Other IDs: | GOO-17-048 |
| Study URL: | https://clinicaltrials.gov/study/NCT03788694 |
Last updated: Sep 29, 2023