Skip to content
Unknown statusPhase 1

Ketamine for Major Depressive Disorder

NCT03721900 · Shenox Pharmaceuticals, LLC

Closed to entry
Status
Not accepting participants
Phase 1
Phase
14
Target enrolment
3
Study sites
3 US states

What it is testing

Summary

The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.

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

  • Pharmacokinetics of SHX-001 (Cmax)

    Measured over 1 week

  • Pharmacokinetics of SHX-001 (Tmax)

    Measured over 1 week

  • Pharmacokinetics of SHX-001 (T1/2)

    Measured over 1 week

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 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Present a current depressive episode of at least 8 weeks * Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening * Agree to use adequate methods of contraception during the study (and for X days after discharge) Exclusion Criteria: * A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry. * Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant. * Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication * A history of drug abuse or dependence within 180 days of screening * A febrile illness within 5 days prior to the first dose of study medication. * A known hypersensitivity to ketamine * A history of use ketamine for Major Depressive Disorder and did not respond to ketamine * Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)

Where

3 study sites

FacilityCityRegionCountry
Clinical Research SiteGaithersburgMarylandUnited States
Clinical Research SiteBostonMassachusettsUnited States
Clinical Research SiteDaytonOhioUnited 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.

NCT03721900 on ClinicalTrials.gov →

Last updated in the registry 2019-04-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits