The objectives are to assess the pharmacokinetic and pharmacodynamic effects of sub-anesthetic ketamine administration, to assess the optimal dose of ketamine and gender differences, to compare different oucome measures for psychomimetic symptoms…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
N/A
Background summary
S(+)-ketamine is a fast acting anesthetic, that induces a dissociative
anesthesia through NMDA antagonism. In a subanesthetic dose, ketamine has been
shown to induce psychomimetic symptoms in both healthy volunteers and patients
with schizophrenia. Therefore, ketamine could be used as an in-human model for
psychosis in healthy volunteers.
Study objective
The objectives are to assess the pharmacokinetic and pharmacodynamic effects of
sub-anesthetic ketamine administration, to assess the optimal dose of ketamine
and gender differences, to compare different oucome measures for psychomimetic
symptoms and to assess the role of personality, psychotic proneness and
genetics on the level of effect.
Study design
This will be a double-blind, randomized, three-way cross-over trial.
Intervention
S(+)-ketamine or placebo, given as an intravenous infusion using target control
drug delivery.
Study burden and risks
N/A
Zernikedreef 10
2333 CL Leiden
NL
Zernikedreef 10
2333 CL Leiden
NL
Listed location countries
Age
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 <= 1x/week in last year)
Willing to provide informed consent to participate in the study and to comply with all study procedures
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-022203-21-NL |
| CCMO | NL33486.058.10 |