Clinical TrialNeuroimaging & Brain MeasuresKetaminePlaceboCompleted

Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers

This randomised controlled trial (n=70) investigated the effects of ketamine on mentalizing and metacognition in healthy volunteers.

Target Enrollment
70 participants
Study Type
Phase IV interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, parallel-group study in healthy volunteers comparing intravenous ketamine infusion (target plasma 100 ng/ml with initial bolus) to saline placebo during performance of a video-based mentalizing (MASC) task in the fMRI scanner.

Aim is to experimentally induce social-cognitive alterations resembling over- or undermentalizing to study neural correlates of theory-of-mind and metacognition using fMRI and behavioural task measures.

Outcomes include task performance on the MASC paradigm, fMRI measures, and safety/tolerability assessments in a healthy adult sample.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV infusion targeting plasma level 100 ng/ml with an initial bolus (2 mg/ml solution).

Interventions

  • Ketamine
    via IV• single dose• 1 doses total

    IV infusion via Graseby 3500 pump and STANPUMP to target plasma 100 ng/ml; initial bolus as 2 mg/ml solution.

Placebo

inactive

Saline (NaCl 0.9%) IV infusion using same pump setup.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    NaCl 0.9% saline IV via Graseby 3500 pump and STANPUMP (placebo comparator).

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • Recruited participants are required to meet the following criteria:
  • Height between 150 and 195 cm
  • Bodyweight between 50 and 99 kg
  • Male or female
  • Right-handed
  • Physically, neurologically and psychiatrically healthy
  • Non-smoker
  • Normal or corrected-to-normal eyesight
  • Good command of German language

Exclusion Criteria

  • Potential participants are excluded based on the following criteria:
  • History of psychiatric/neurological disorder (self and first-degree relatives)
  • Learning disabilities, or loss of consciousness for more than 5 minutes
  • History of alcohol or drug abuse within the last 12 months
  • History of ketamine abuse
  • History of complications during anesthesia (self and first-degree relatives)
  • Serious physical illness
  • Claustrophobia
  • Colour-blindness
  • Metalliferous implant
  • Visual impairments other than corrective lenses
  • Injury or disease of the inner ear with loss of hearing
  • Consumption of any prescription or over-the-counter medication 3 days previous to the examination
  • Pregnancy
  • Currently breastfeeding a baby
  • Hypotension (blood pressure < 100/60)
  • Hypertension (blood pressure > 140/90)
  • Underweight (BMI <17)
  • Overweight (BMI ≥30)

Study Details

Locations

Department of Psychiatry and Psychotherapy, University Hospital Bonn — Bonn, Germany

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