Intranasal Ketamine for Suicidal Ideation in Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Ketamine<br>Subjects will receive study medication, intranasal ketamine. | Drug: Ketamine<br>* 8 doses of intranasal ketamine; 40 mg per dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks | 
| 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. | Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Veteran, Suicide, Suicidal Ideation