Ketamine for Major Depressive Disorder

• Status: Unknown status
• Trial end date: 2019-06-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenox Pharmaceuticals, LLC
• Treatments: Ketamine

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)