Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboKetamineUnknown status

Ketamine for Major Depressive Disorder

Phase I single-blind sequential study (n=14) assessing PK, safety and antidepressant effects of SHX-001 ketamine transdermal patch (20 mg low, 40 mg high) versus placebo in adults with MDD.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Non-randomized, single Blind

Detailed Description

SHX-C301 is a Phase 1, first-in-human, single-blind, multi-centre sequential study to evaluate the pharmacokinetics, safety and antidepressant effects of SHX-001 transdermal patch in subjects with MDD inadequately controlled by standard of care.

Each subject will receive placebo, low dose (20 mg) and high dose (40 mg) patches in the same order across three study periods; primary outcomes include PK measures and safety/tolerability and exploratory antidepressant effects.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

SHX-001 low

experimental

SHX-001 transdermal patch low dose (20 mg)

Interventions

  • Ketamine20 mg
    via Topical• single dose• 1 doses total

    SHX-001 Active low dose (20 mg) transdermal patch

Placebo patch

inactive

Placebo transdermal patch

Interventions

  • Placebo
    via Topical• single dose• 1 doses total

    Placebo transdermal patch

SHX-001 high

experimental

SHX-001 transdermal patch high dose (40 mg)

Interventions

  • Ketamine40 mg
    via Topical• single dose• 1 doses total

    SHX-001 Active high dose (40 mg) transdermal patch; high dose delivered based on low-dose PK estimation

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion 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

  • 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)

Study Details

Locations

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

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