Ketamine for Major Depressive Disorder

Phase 1

• Conditions: Major Depressive Disorder
• Interventions: Drug: SHX-001 Active low dose; Drug: Placebo; Drug: SHX-001 Active High dose

• Registration Number: NCT03721900
• Lead Sponsor: Shenox Pharmaceuticals, LLC

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.

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-26
• Study Start: 2018-12-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SHX-001 Active Low Dose	SHX-001 Active low dose	Ketamine transdermal patch
Placebo	Placebo	placebo transdermal patch
SHX-001 Active high dose	SHX-001 Active High dose	ketamine transdermal patch

Primary Outcome Measures

Name	Time	Method
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
Pharmacokinetics of SHX-001 (Cmax)	1 week	Maximum observed plasma concentration

Secondary Outcome Measures

Name	Time	Method
Anti-depressive effects of SHX-001	1 week	Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Dayton, Ohio, United States