Clinical TrialDepressive DisordersKetamineUnknown status

Use of Transmucosal Ketamine in Post Stroke Depression

Open-label, single-group Phase I study (n=21) testing transmucosal ketamine 0.5 mg/kg (two weekly doses) for treatment of post-stroke depression to assess feasibility, safety and exploratory antidepressant effects.

Target Enrollment
21 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This open-label single-group study evaluates the feasibility and safety of transmucosal (sublingual) ketamine at 0.5 mg/kg administered twice, one week apart, in patients with post-stroke depression.

Primary aims are tolerability and feasibility; exploratory measures assess rapid antidepressant effects and safety signals to inform larger translational studies in the post-stroke population.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine dose

experimental

Open-label, single-group transmucosal ketamine 0.5 mg/kg administered beneath the tongue; two doses 1 week apart.

Interventions

  • Ketamine0.5 mg/kg
    via Sublingual• weekly• 2 doses total

    Place liquid beneath tongue, hold for 5 minutes; pharmacy prepares weight-based syringes.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Men and women (18 years of age or older) of any ethnicity diagnosed with Major Depressive Disorder (DSM-V criteria), who have had failed to respond to prior therapy (defined as at least one antidepressant trial or intolerant/noncompliant with antidepressant medications).
  • Willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing.
  • Understands and willing to undergo risks associated with adverse effects of study medications.
  • Willing to comply with restrictions and instructions disclosed in the consent form.

Exclusion Criteria

  • Exclusion Criteria:
  • Patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration.
  • Patients with a diagnosis of epilepsy.
  • Patients with a significant history of high intraocular pressure.
  • Patients with life threatening medical problems.
  • Participant is pregnant or breastfeeding.
  • Infants and children.
  • Patients who lack medical decision-making capacity.
  • Patients who would require medication adjustment during time in the study.
  • Known hypersensitivity to the study drug (ketamine).
  • Unwilling to undergo risks associated with adverse effects of study drugs.
  • Unwilling to comply with restrictions and instructions disclosed in the consent form.

Study Details

  • Status
    Unknown status
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment21 participants
  • Timeline
    Start: 2020-11-30
    End: 2022-11-01
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

WVU Medicine — Morgantown, West Virginia, United States

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