Pharmacological Magnetic Resonance Spectroscopy

Completed

Conditions: There is no specific disease being investigated
10037173

Registration Number: NL-OMON49551

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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);
* 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Change in levels of GABA, glutamate, and lactate in the mPFC;<br /><br>* phMRI signal in the mPFC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Functional connectivity, with the prefrontal cortex as important region of<br /><br>interest<br /><br>* Score on a VAS, to quantify the subjective effect of S-ketamine<br /><br>* CADSS to monitor changes in dissociative state due to placebo or ketamine<br /><br>administration.<br /><br>* Blood samples will be obtained at several time points to assess the plasma<br /><br>concentration of S-ketamine and its active metabolite norketamine. </p><br>