Ketamine for Major Depressive Disorder

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT03721900

Run by

Shenox Pharmaceuticals, LLC

People needed

14

Starts

2018-12-28

Expected to finish

2019-06-06

Last updated by the study team

2019-04-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Clinical Research Site — Gaithersburg, Maryland, United States
• Clinical Research Site — Boston, Massachusetts, United States
• Clinical Research Site — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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