Major Depressive Disorder
Conditions
Keywords
Depression
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.
Detailed 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.
Interventions
DRUGSHX-001 Active low dose
ketamine transdermal patch
DRUGPlacebo
transdermal patch
DRUGSHX-001 Active High dose
ketamine transdermal patch
Sponsors
Shenox Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Each subject will receive one of the following: placebo, 20 mg (low dose), or 40 mg (high dose). All subjects will receive doses in the same order during 3 study periods
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of SHX-001 (Cmax) | 1 week | Maximum observed plasma concentration |
| Pharmacokinetics of SHX-001 (Tmax) | 1 week | Time of maximum observed plasma concentration |
| Pharmacokinetics of SHX-001 (T1/2) | 1 week | Apparent terminal half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-depressive effects of SHX-001 | 1 week | Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001) | Up to 10 weeks | The safety and tolerability of SHX-001 transdermal patch as an adjunctive therapy to standard of care will be evaluated in subjects with MDD who are sub-optimally responsive to approved antidepressant. |
Countries
United States
Outcome results
None listed