Ketamine for Major Depressive Disorder

NCT03721900 | Unknown Phase 1 FDA Drug

• 1 other identifier: SHX-C301
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

Conditions

Major Depressive Disorder

Keywords

Depression

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of SHX-001 (Cmax)

  Maximum observed plasma concentration

  1 week

• Pharmacokinetics of SHX-001 (Tmax)

  Time of maximum observed plasma concentration

  1 week

• Pharmacokinetics of SHX-001 (T1/2)

  Apparent terminal half-life

  1 week

Secondary Outcomes (1)

• Anti-depressive effects of SHX-001

  1 week

Other Outcomes (1)

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

  Up to 10 weeks

Study Arms (3)

SHX-001 Active Low Dose

EXPERIMENTAL

Ketamine transdermal patch

Drug: SHX-001 Active low dose

Placebo

PLACEBO COMPARATOR

placebo transdermal patch

Drug: Placebo

SHX-001 Active high dose

EXPERIMENTAL

ketamine transdermal patch

Drug: SHX-001 Active High dose

Interventions

SHX-001 Active low dose DRUG

ketamine transdermal patch

Also known as: Ketamine transdermal patch

SHX-001 Active Low Dose

Placebo DRUG

transdermal patch

Also known as: placebo transdermal patch

Placebo

SHX-001 Active High dose DRUG

ketamine transdermal patch

Also known as: ketamine transdermal patch

SHX-001 Active high dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shenox Pharmaceuticals, LLC: lead

Study Sites (3)

Clinical Research Site

Gaithersburg, Maryland, 20877, United States

Location

Clinical Research Site

Boston, Massachusetts, 02114, United States

Location

Clinical Research Site

Dayton, Ohio, 45417, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mason Freeman, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 26, 2018
• Study Start: December 28, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)