Ketamine for Major Depressive Disorder

April 24, 2019 updated by: Shenox Pharmaceuticals, LLC

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Research Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHX-001 Active Low Dose
Ketamine transdermal patch
ketamine transdermal patch
Other Names:
  • Ketamine transdermal patch
Placebo Comparator: Placebo
placebo transdermal patch
transdermal patch
Other Names:
  • placebo transdermal patch
Experimental: SHX-001 Active high dose
ketamine transdermal patch
ketamine transdermal patch
Other Names:
  • ketamine transdermal patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)
Time Frame: 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.
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mason Freeman, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2018

Primary Completion (Anticipated)

June 6, 2019

Study Completion (Anticipated)

June 6, 2019

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on SHX-001 Active low dose

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