Ketamine for Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: SHX-001 Active low dose
* Drug: Placebo
* Drug: SHX-001 Active High dose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHX-001 Active Low Dose<br>Ketamine transdermal patch | Drug: SHX-001 Active low dose<br>* ketamine transdermal patch<br>* Other names: Ketamine transdermal patch;|
| Placebo Comparator: Placebo<br>placebo transdermal patch | Drug: Placebo<br>* transdermal patch<br>* Other names: placebo transdermal patch;|
| Experimental: SHX-001 Active high dose<br>ketamine transdermal patch | Drug: SHX-001 Active High dose<br>* ketamine transdermal patch<br>* Other names: ketamine transdermal patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of SHX-001 (Cmax) | Maximum observed plasma concentration | 1 week | 
| Pharmacokinetics of SHX-001 (Tmax) | Time of maximum observed plasma concentration | 1 week | 
| Pharmacokinetics of SHX-001 (T1/2) | Apparent terminal half-life | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-depressive effects of SHX-001 | Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated) | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression