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.
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 |
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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