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Ketamine for Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SHX-001 Active low dose

Placebo

SHX-001 Active High dose

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Clinical Research Site
Clinical Research Site
Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

SHX-001 Active Low Dose

Placebo

SHX-001 Active high dose

Arm Description

Ketamine transdermal patch

placebo transdermal patch

ketamine transdermal patch

Outcomes

Primary Outcome Measures

Pharmacokinetics of SHX-001 (Cmax)

Maximum observed plasma concentration

Pharmacokinetics of SHX-001 (Tmax)

Time of maximum observed plasma concentration

Pharmacokinetics of SHX-001 (T1/2)

Apparent terminal half-life

Secondary Outcome Measures

Anti-depressive effects of SHX-001

Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)

Full Information

NCT ID

NCT03721900

First Posted

October 18, 2018

Last Updated

April 24, 2019

Sponsor

Shenox Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03721900

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 28, 2018 (Actual)

Primary Completion Date

June 6, 2019 (Anticipated)

Study Completion Date

June 6, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenox Pharmaceuticals, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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

Participant

Allocation

Non-Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHX-001 Active Low Dose

Arm Type

Experimental

Arm Description

Ketamine transdermal patch

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo transdermal patch

Arm Title

SHX-001 Active high dose

Arm Type

Experimental

Arm Description

ketamine transdermal patch

Intervention Type

Drug

Intervention Name(s)

SHX-001 Active low dose

Other Intervention Name(s)

Ketamine transdermal patch

Intervention Description

ketamine transdermal patch

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

placebo transdermal patch

Intervention Description

transdermal patch

Intervention Type

Drug

Intervention Name(s)

SHX-001 Active High dose

Other Intervention Name(s)

ketamine transdermal patch

Intervention Description

ketamine transdermal patch

Primary Outcome Measure Information:

Title

Pharmacokinetics of SHX-001 (Cmax)

Description

Maximum observed plasma concentration

Time Frame

1 week

Title

Pharmacokinetics of SHX-001 (Tmax)

Description

Time of maximum observed plasma concentration

Time Frame

1 week

Title

Pharmacokinetics of SHX-001 (T1/2)

Description

Apparent terminal half-life

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Anti-depressive effects of SHX-001

Description

Antidepressant effects will be explored by assessing changes in depression assessments (clinician and self-rated)

Time Frame

1 week

Other Pre-specified Outcome Measures:

Title

Safety objective as measured by Adverse Events (Safety and Tolerability of SHX-001)

Description

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.

Time Frame

Up to 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mason Freeman, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Site

City

Gaithersburg

State/Province

Maryland

ZIP/Postal Code

20877

Country

United States

Facility Name

Clinical Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Clinical Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Ketamine for Major Depressive Disorder

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