Pharmacological Magnetic Resonance Spectroscopy
- Conditions
- A
- Registration Number
- NL-OMON29216
- Lead Sponsor
- Amsterdam University Medical Center, location AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
? 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
? (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in levels of GABA, glutamate, and lactate in PFC; phMRI signal in PFC.
- Secondary Outcome Measures
Name Time Method ? Functional connectivity<br>? Score on a Visual Analog Scale (VAS), to quantifies subjective measure of the sedative effect<br>of S-ketamine<br>? Clinician Administered Dissociative States Scale (CADSS) to monitor changes in<br>dissociative state due to placebo or ketamine administration.<br>? Blood samples will be obtained at several time points to assess the plasma concentration<br>of S-ketamine and its active metabolite S-norketamine.