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Pharmacological Magnetic Resonance Spectroscopy

Pharmacological Magnetic Resonance Spectroscopy - phMRS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49551
Enrollment
30
Registered
2020-09-22
Start date
2021-04-07
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

There is no specific disease being investigated

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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;

Design outcomes

Primary

MeasureTime frame
* Change in levels of GABA, glutamate, and lactate in the mPFC; * phMRI signal in the mPFC.

Secondary

MeasureTime frame
* Functional connectivity, with the prefrontal cortex as important region of interest * Score on a VAS, to quantify the subjective effect of S-ketamine * 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 norketamine.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)