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CompletedN/A

Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine

NCT04856124 · Psych Atlanta

Closed to entry
Status
Not accepting participants
Not applicable
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study aims to assess the efficacy and safety of intranasal esketamine as maintenance antidepressant therapy in patients who have demonstrated clinical improvement with off-label intravenous racemic ketamine for treatment-resistant 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-Asberg Depression Rating Scale (MADRS)

    Measured over 12 months

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
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: Diagnosis of major depression, recurrent, severe without psychotic symptoms according to criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Must be diagnosed with Treatment resistant depression. 18 years old and up Patients had a clinically meaningful response to a course of IV racemic ketamine Exclusion Criteria: Active substance abuse, psychosis, significant medical comorbidities, or axis II diagnosis that would interfere with the reliability of outcome measures or response to pharmacotherapy.

Where

1 study site

FacilityCityRegionCountry
PsychAtlantaMariettaGeorgiaUnited 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.

NCT04856124 on ClinicalTrials.gov →

Last updated in the registry 2021-04-23. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in