Clinical TrialHealthy VolunteersKetaminePlaceboUnknown status

Reward Emotion Learning and Ketamine Study

Randomised, double-blind, parallel healthy volunteer study (n=70) testing a single IV ketamine infusion (0.5 mg/kg) versus placebo to examine effects on reward learning and memory.

Target Enrollment
70 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This parallel, randomised, double-blind study in healthy volunteers examines how a single antidepressant dose of ketamine (0.5 mg/kg IV) alters reward-emotion learning and memory compared with placebo.

Participants complete tasks assessing learning about reward and punishment and memory for learned reward associations, with neural measures collected to characterise mechanisms underlying ketamine's antidepressant effects.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV antidepressant dose of ketamine hydrochloride (0.5 mg/kg).

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Ketamine hydrochloride 0.5 mg/kg IV single infusion.

Placebo

inactive

Single IV injection of inactive placebo (0.9% sodium chloride).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% sodium chloride IV single injection (placebo).

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • BMI between 18 and 30
  • Participant is willing and able to give informed consent for participation in the study
  • Sufficient knowledge of English language to understand and complete study tasks
  • Willingness to refrain from driving, cycling, or operating heavy machinery, until the following morning or a restful sleep has occurred, whichever is later.
  • Willingness to refrain from signing legal documents within 7 days after the infusion visit.
  • Willingness to refrain from drinking alcohol for 3 days before the infusion visit and one day before any of the other visits throughout the study

Exclusion Criteria

  • Exclusion Criteria:
  • Any current or past DSM-V significant psychiatric disorder including any psychotic, mood and anxiety and borderline personality disorders
  • History of, or current medical conditions which in the opinion of the investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, hepatic or renal disease, severe gastro-intestinal problems, Central Nervous System (CNS) tumours, neurological conditions
  • First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder, or bipolar disorder
  • History of unexplained hallucinations or impulse control problems (e.g. pathological gambling)
  • Current or past history of heart rhythm disorders
  • Clinically significant hypertension
  • Increased intraocular pressure/glaucoma
  • Current pregnancy (as determined by urine pregnancy test taken during Screening and Infusion Visits) or breastfeeding
  • Clinically significant abnormal values for clinical chemistry (e.g. liver function tests), urine drug screen, blood pressure measurement and ECG. A participant with a clinical abnormality or parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
  • Current or previous intake (last three months) of any medication that has a significant potential to affect mental functioning (e.g. benzodiazepines, antidepressants, neuroleptics etc.)
  • Any intake of recreational drugs in the last 3 months (e.g. marijuana, ecstasy etc.)
  • Lifetime recreational use of ketamine or phencyclidine
  • Regular alcohol consumption of more than 14 units a week or excessive alcohol consumption up to three days before any of the in-person study visits
  • Inability to abstain from alcohol for more than 1 week
  • Regular smoker (\> 5 cigarettes per day)
  • Excessive caffeine user (\> 6 caffeinated drinks per day)
  • History of recurrent rashes or history of allergic reactions to relevant substances (ketamine treatment, placebo treatment)
  • Previous participation in a study using the same or similar tasks
  • Current participation in another study or participation in similar study within the last 6 months
  • Participant is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator
  • Claustrophobia
  • Any implants (including dental implants) or pacemaker
  • Tattoos above the chest
  • Any other MRI contraindications outlined in FMRIB 7 Tesla scanning safety form

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment70 participants
  • Timeline
    Start: 2021-01-04
    End: 2022-01-11
  • Compounds
    KetaminePlacebo
  • Topic
    Healthy Volunteers

Locations

University of Oxford — Oxford, United Kingdom

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