Clinical TrialHealthy VolunteersEsketaminePlaceboKetaminePlaceboEsketaminePlaceboRecruiting

Imaging Neural Correlates of Ketamine Using PET/MR

Randomized, placebo-controlled, double-blind crossover PET/MR study (n=65) comparing IV racemic ketamine and IV esketamine versus placebo in healthy adults to investigate pharmacodynamic differences using [18F]FDG PET/MR.

Target Enrollment
65 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This is a randomized, double-blind, placebo-controlled crossover study using [18F]FDG PET/MR to compare pharmacodynamic effects of intravenous racemic ketamine and esketamine in healthy adult volunteers.

The protocol includes pilot studies: a pilot for pharmacokinetics/acute behavioural effects and a Pilot II of 15 healthy volunteers to optimise scanning procedures (two-scan crossover). The main study uses a three-scan schedule with placebo at first scan and active drug at subsequent scans in crossover assignment.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Esketamine

experimental

IV esketamine infusion during PET/MR; placebo (saline) infusion at first scan with crossover to active in subsequent scan.

Interventions

  • Esketamine
    via IV• single dose• 1 doses total

    IV infusion during PET/MR; single active session per subject in crossover.

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo infusion performed during first scan.

Racemic ketamine

experimental

IV racemic ketamine infusion during PET/MR; placebo (saline) infusion at first scan with crossover to active in subsequent scan.

Interventions

  • Ketamine
    via IV• single dose• 1 doses total

    IV infusion of racemic ketamine during PET/MR; single active session per subject in crossover.

  • Placebo
    via IV• single dose• 1 doses total

    Saline placebo infusion performed during first scan.

Pilot II: Esketamine

experimental

Pilot crossover: esketamine versus placebo across two scans to optimise scanning procedures.

Interventions

  • Esketamine
    via IV• single dose• 1 doses total

    Pilot IV esketamine infusion during PET/MR.

  • Placebo
    via IV• single dose• 1 doses total

    Pilot saline placebo infusion.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • General health based on medical history, physical examination and structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID)
  • Age 18 to 55 years
  • Right-handedness (due to potential lateralization effects of left-handed subjects)
  • Willingness and competence to sign the informed consent form.

Exclusion Criteria

  • Exclusion Criteria:
  • Current or history of psychiatric or neurological disease
  • Current medical illness requiring treatment
  • Pregnancy or current breastfeeding
  • Current or former substance abuse
  • Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
  • Any contraindication for MRI (e.g., MR incompatible implants, including dental implants causing signal artefacts)
  • Prior participation producing radiation exposure that causes total >30 mSv over last 10 years per Austrian regulations; body weight >100 kg (radiation dose constraint)
  • Failure to comply with the study protocol or to follow instructions of the investigating team.

Study Details

Locations

Medical University of Vienna — Vienna, Austria

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