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IV Ketamine vs. IN Esketamine for MDD TRD

NCT06488586 · Gustavo Vazquez

Recruiting
Status
Accepting participants
Not applicable
Phase
80
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this observational study is to learn about the comparative acute effects of ketamine vs esketamine in participants over the age of 18 for the treatment of their severe depression and suicidal ideations. Participants are already taking antidepressants and/or antipsychotics as part of their regular medical care for depression,

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

  • Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured over From enrollment to the end of treatment at 4 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

18 Years to 75 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Adult outpatients (18-75 years old) with unipolar depression experiencing major depressive episodes as determined by the DSM5 and characterized as MDD-TRD (diagnosed with major depressive disorder as outlined by the DSM5) and experienced at least two previous failed antidepressant treatments of adequate dose and duration for the current episode Exclusion Criteria: * Individuals with psychosis, main diagnosis of personality disorder, uncontrolled hypertension, substance abuse, currently pregnant or breastfeeding, or who had a previous negative reaction to ketamine or esketamine, were ineligible to receive IV ketamine or IN esketamine.

Where

1 study site

FacilityCityRegionCountry
Providence Care HospitalKingstonOntarioCanada

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.

NCT06488586 on ClinicalTrials.gov →

Last updated in the registry 2024-07-10. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 2 trials from Gustavo Vazquez →