Ketamine for Major Depressive Disorder

Shenox Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: SHX-001 Active High dose; Drug: SHX-001 Active low dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03721900

SHX-C301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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14 participants in 3 patient groups, including a placebo group

SHX-001 Active Low Dose

Experimental group

Description:

Ketamine transdermal patch

Treatment:

Drug: SHX-001 Active low dose

Placebo

Placebo Comparator group

Description:

placebo transdermal patch

Treatment:

Drug: Placebo

SHX-001 Active high dose

Experimental group

Description:

ketamine transdermal patch

Treatment:

Drug: SHX-001 Active High dose