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Ketamine for Treatment Resistant MDD

NCT04021433 · Hadassah Medical Organization

Closed to entry
Status
Not accepting participants
Not applicable
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

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

  • MADRS

    Measured over 1 month into treatment through study completion

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 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Diagnosed with unipolar/bipolar depression with MADRS Score\>= 20 * Inadequate response to \>= 3 adequate treatment trials \[\>=2 trials in the present episode\] * If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment * QTc WNL Exclusion Criteria: * Hypersensitivity to ketamine * Other major psychiatric diagnosis * High suicidality * Unstable physical illness * S/P CVA / brain SOL * Pregnant or breast feeding women * Illicit drug/alcohol abuse during last year * History of ketamine abuse

Where

1 study site

FacilityCityRegionCountry
Hadassah Hebrew University Medical CenterJerusalem—Israel

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.

NCT04021433 on ClinicalTrials.gov →

Last updated in the registry 2019-07-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 3 trials from Hadassah Medical Organization →