A randomised, double blind, placebo-controlled cross-over study to investigate the effects of intravenous S(+)-ketamine on functional brain connectivity using fMRI in healthy volunteers.
- Conditions
- fMRI onderzoek in gezonde vrijwilligersnot applicable
- Registration Number
- NL-OMON34353
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
healthy volunteers
age 18-45
right handed
naive to Ketanest-S
Obesity (BMI > 30);
Significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease.
History of illness, condition or medication use that, in the opinion of the investigator, might interfere with optimal participation, confound the results of the study or pose additional risk in administering S(+)-ketamine to the subject or in making the MRIs
History of chronic alcohol or illicit drug use;
Unable to refrain from quinine containing products and grapefruit or grapefruit juice from 7 days prior to study start until the last study day.
Metal medical devices like pacemakers, knee or hip prosthesis, ear implants, vessel clips, subcutaneous insulin pumps or carries metal particles (e.g. metal splinter in the eye) inside the body.
Claustrophobia.
Allergy to study medications;
Not able to maintain a regular diurnal rhythm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>resting state network (fMRI)</p><br>
- Secondary Outcome Measures
Name Time Method <p>arterial spin labeling (fMRI)<br /><br>plasma concentrations of S(+)-ketamine and S(+)-norketamine<br /><br>pain relief<br /><br>side effects</p><br>