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WithdrawnEarly Phase 1

Intranasal Ketamine for Suicidal Ideation in Veterans

NCT03788694 · Bronx Veterans Medical Research Foundation, Inc

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Beck Scale for Suicidal Ideation (BSSI)

    Measured over Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
James J. Peters VA Medical CenterThe BronxNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03788694 on ClinicalTrials.gov →

Last updated in the registry 2023-08-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in