Clinical trial NCT03721900: Ketamine for Major Depressive Disorder
Official title: A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: Shenox Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pharmacokinetics of SHX-001 (Cmax)
timeFrame: 1 week
measure: Pharmacokinetics of SHX-001 (Tmax)
timeFrame: 1 week
measure: Pharmacokinetics of SHX-001 (T1/2)
timeFrame: 1 week
Secondary outcomes:
measure: Anti-depressive effects of SHX-001
timeFrame: 1 week
Other outcomes:
measure: Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)
timeFrame: Up to 10 weeks
Locations:
city: Gaithersburg
country: United States
facility: Clinical Research Site
state: Maryland
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Dayton
country: United States
facility: Clinical Research Site
state: Ohio
Study officials:
affiliation: Massachusetts General Hospital
name: Mason Freeman, MD
role: STUDY_DIRECTOR
References: