Ketamine for Major Depressive Disorder

Brief 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.

Intervention / Treatment

  • Drug: SHX-001 Active low dose
  • Drug: Placebo
  • Drug: SHX-001 Active High dose

Condition or Disease

  • Major Depressive Disorder

Phase

Study Design

Study type: Interventional
Status: Active, not recruiting
Study results: No Results Available
Age: 18 Years to 70 Years   (Adult, Older Adult)
Enrollment: 14 ()
Funded by: Industry

Masking

Clinical Trial Dates

Start date: Dec 28, 2018
Primary Completion: Jun 06, 2019
Completion Date: Jun 06, 2019
Study First Posted: Oct 26, 2018
Results First Posted: Aug 31, 2020
Last Updated: Apr 25, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 70

More Details

NCT Number: NCT03721900
Other IDs: SHX-C301
Study URL: https://ClinicalTrials.gov/show/NCT03721900
Last updated: Jun 16, 2022