psychotic disorder schizophrenia
Conditions
Interventions
S(+)-ketamine or placebo, given as an intravenous infusion using target control
drug delivery.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 45 (extremes included) Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes included) Mild cannabis users (defined as >= 4 times in last year and
Exclusion criteria
Exclusion criteria: Clinically significant (history of) disease as determined by medical history, physical examination, ECG or routine blood chemistry, hematology or virology tests. Clinically significant (history of) psychiatric illnesses (including substance abuse) or (history of) psychotic symptoms Family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree) Smokes more than five cigarettes a day Positive urine drug screen for recreational drugs (i.e. cocaine, opioids, benzodiazepines, amphetamines, metamphetamines, MDMA or THC) Positive urine pregnancy test or breastfeeding Exposure to medication (including St. John's Wort) known to interfere with CYP3A4 metabolism within 14 days prior to dosing Unable or unwilling to refrain from smoking, heavy physical exercise or the use of alcohol, xanthine, or grapefruit juice 24 hours prior to dosing until discharge. Blood loss or donation outside the limits of the Dutch blood bank (Sanquin) Participation in a clinical study within the past three months, or participation within four or more clinical studies in the past twelve months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and negative syndrome scale (PANSS), pre-pulse inhibition (PPI), visual analogue scales (VAS Bowdle and VAS Bond and Lader), eye movements (saccadic and smooth pursuit), pupillometry, body sway and pharmacokinetics (S(+)-ketamine and S(+)-norketamine). | — |
Countries
Netherlands
Outcome results
None listed