No registrations found.
ID
Source
Brief title
Health condition
NA
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in levels of GABA, glutamate, and lactate in PFC; phMRI signal in PFC.
Secondary outcome
● Functional connectivity
● Score on a Visual Analog Scale (VAS), to quantifies subjective measure of the sedative effect
of S-ketamine
● Clinician Administered Dissociative States Scale (CADSS) to monitor changes in
dissociative state due to placebo or ketamine administration.
● Blood samples will be obtained at several time points to assess the plasma concentration
of S-ketamine and its active metabolite S-norketamine.
Background summary
Pharmacological magnetic resonance imaging (phMRI), which measures the blood
flow response to drug-induced neuronal activation, is a promising technique to non-invasively
assess the brain’s response to psychotropic medication. However, phMRI measures are blood flow
based and therefore often contaminated by (systemic) cardiovascular effects frequently induced
by psychotropic medication. Magnetic resonance spectroscopy has been suggested as a technique
to more directly assess drug-induced neuronal activity and therefore allow a more complete
characterization of the brain response to psychotropic medication. We hypothesise that
concurrent measurements of the hemodynamic response and glutamate/GABA levels (with MRS)
during drug administration will provide the much-needed information to interpret the underlying
neuronal contribution to the phMRI signal. The aim of the proposed study is to provide evidence
for this hypothesis.
Study objective
We hypothesize that added neurometabolite measurements can contribute to the interpretation of the ketamine phMRI response.
Study design
screening and 3 visits, at least 1 week apart
Intervention
Subjects will receive intravenous 0.11 mg/kg S-ketamine, 0.22 mg/kg S-ketamine or placebo during a phMRI/phMRS scan on different test sessions in
randomized order.
Inclusion criteria
● Healthy volunteers between 18 and 55 years old;
● BMI between 18.5 and 25;
● Male or female;
● If female: using oral contraceptives and not in hormone-free week during scanning
Exclusion criteria
● (History of) psychiatric treatment, for which prescription medication is used;
● First-degree relative with (history of) schizophrenia or major depression;
● (History) of neurological disorders (including stroke, convulsion, epilepsy) as well as concussion
with loss of consciousness
● Contraindications for S-ketamine (e.g. allergy for S-ketamine, or one of the inactive ingredients
of this product, high BP (RRsystolic > 180 mmHg or diastolic >100 mmHg), use of xantiderivatives
or methylergometrine); use of substances that interact with S-ketamine (e.g. grapefruit juice, antifungal medication)
● Contraindications for 7T MRI (e.g. claustrophobia, osteosynthetic material, pacemaker, artificial
cardiac valves);
● (History of) drug (opiate, LSD, (meth)amphetamine, cocaine, solvents, cannabis, or barbiturate)
or alcohol dependence;
● Used psychotropic medication, or recreational drugs over a period of 1 week prior to each test
session;
● Used alcohol within the last 24 hours prior to each test session.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8994 |
| CCMO | NL74447.018.20 |
| OMON | NL-OMON49551 |