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Clinical Trial 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.


Clinical Trial Description

SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03721900
Study type Interventional
Source Shenox Pharmaceuticals, LLC
Contact Tiffany Chan, MMSc
Phone 6176439925
Email tchan@ccib.mgh.harvard.edu
Status Not yet recruiting
Phase Phase 1
Start date November 15, 2018
Completion date June 6, 2019

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