UnknownPhase 1ketamine
Ketamine for Major Depressive Disorder
Sponsored by Shenox Pharmaceuticals, LLC
NCT ID
NCT03721900
Target Enrollment
14 participants
Start Date
2018-12-28
Est. Completion
2019-06-06
About This Study
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.
Conditions Studied
Interventions
- •SHX-001 Active low dose
- •Placebo
- •SHX-001 Active High dose
Eligibility
Age:18 Years - 70 Years
Healthy Volunteers:No
View full eligibility criteria
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)
Study Locations (3)
Clinical Research Site
Gaithersburg, Maryland, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Dayton, Ohio, United States