Ketamine for Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-28

Study Completion Date

2019-06-06

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.

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SHX-001 Active Low Dose

Ketamine transdermal patch

Group Type EXPERIMENTAL

SHX-001 Active low dose

Intervention Type DRUG

ketamine transdermal patch

Placebo

placebo transdermal patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

transdermal patch

SHX-001 Active high dose

ketamine transdermal patch

Group Type EXPERIMENTAL

SHX-001 Active High dose

Intervention Type DRUG

ketamine transdermal patch

Interventions

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SHX-001 Active low dose

ketamine transdermal patch

Intervention Type DRUG

Placebo

transdermal patch

Intervention Type DRUG

SHX-001 Active High dose

ketamine transdermal patch

Intervention Type DRUG

Other Intervention Names

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Ketamine transdermal patch placebo transdermal patch ketamine transdermal patch

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No