The F-KET study.
- Conditions
- (psychomimetic) side effects, S(+)-ketamine, resting state fMRI, healthy volunteers(psychomimetische) bijwerkingen, S(+)-ketamine, resting state fMRI, gezonde vrijwilligers
- Registration Number
- NL-OMON23425
- Lead Sponsor
- eiden University Medical Center (LUMC), Leiden, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Healthy male;
2. Right handed subjects;
Exclusion Criteria
1. Obesity (BMI > 30);
2. 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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. fMRI: whole-brain, voxel-wise RSN brain activity;<br /><br>2. ASL: whole brain, voxel-wise CBF (millilitres of blood per 100g of tissue per minute) and CBF changes due to drug administration;<br /><br>3. S(+)-ketamine and S(+)-norketamine plasma concentrations.
- Secondary Outcome Measures
Name Time Method 1. Visual Analogue Scale (VAS) to assess mood, alertness and calmness (Bond and Lader);<br /><br>2. VAS to assess psychedelic effects (Bowdle);<br /><br>3. VAS to assess heat pain stimulus.