Ketamine for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03721900
• Other study ID #: SHX-C301
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 28, 2018
• Est. completion date: June 6, 2019

Study information

• Verified date: April 2019
• Source: Shenox Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• SHX-001 Active low dose
ketamine transdermal patch
• Placebo
transdermal patch
• SHX-001 Active High dose
ketamine transdermal patch

Locations

Country	Name	City	State
United States	Clinical Research Site	Boston	Massachusetts
United States	Clinical Research Site	Dayton	Ohio
United States	Clinical Research Site	Gaithersburg	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Shenox Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)	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.	Up to 10 weeks
Primary	Pharmacokinetics of SHX-001 (Cmax)	Maximum observed plasma concentration	1 week
Primary	Pharmacokinetics of SHX-001 (Tmax)	Time of maximum observed plasma concentration	1 week
Primary	Pharmacokinetics of SHX-001 (T1/2)	Apparent terminal half-life	1 week
Secondary	Anti-depressive effects of SHX-001	Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)	1 week