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The F-KET study.


- candidate number8333
- NTR NumberNTR2465
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2010
- Secondary IDsP10.136 CME LUMC
- Public TitleThe F-KET study.
- Scientific TitleA randomised, double blind, placebo-controlled cross-over study to investigate the effects of intravenous S(+)-ketamine on resting state functional magnetic resonance imaging in healthy volunteers.
- ACRONYM
- hypothesisS(+)-ketamine influences resting state fMRI in a dose-dependent fashion.
- Healt Condition(s) or Problem(s) studiedHealthy subjects, Resting state fMRI, S(+)-ketamine, (Psychomimetic) side effects
- Inclusion criteria1. Healthy male;
2. Right handed subjects;
3. Naive to ketamine;
4. Between 18 to 45 years of age.
- Exclusion criteria1. 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;
3. 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;
4. History of chronic alcohol or illicit drug use;
5. Unable to refrain from quinine containing products and grapefruit or grapefruit juice from 7 days prior to study start until the last study day;
6. 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;
7. Claustrophobia;
8. Allergy to study medications;
9. Not able to maintain a regular diurnal rhythm.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate1-okt-2011
- Target number of participants12
- InterventionsThe study consists of 2 study days on which the volunteers receives S(+)-ketamine on one study day and placebo (NaCl 0,9%) on the other study day in a randomised fashion. On the study days two intravenous cannulae (one cannula for infusion of the S(+)-ketamine or placebo, one cannula for blood sampling) will be placed. After the first fMRI scan has been made, the infusion of the study medication will start. 50 minutes after the start of the infusion a fMRI scan will be made, after which the infusion rate is increased. 50 minutes after the adaptation of the infusion rate, another fMRI scan will be performed. After this scan the infusion will be stopped. During the elimination phase another 2 fMRI scans will be made. Before, during and after infusion S(+)-ketamine and S(+)-norketamine plasma concentrations and pharmacodynamic measurements will be obtained at specified times until approximately 3 hours after the start of the infusion. Also side effects are measured with questionnaires.
- Primary outcome1. fMRI: whole-brain, voxel-wise RSN brain activity;
2. ASL: whole brain, voxel-wise CBF (millilitres of blood per 100g of tissue per minute) and CBF changes due to drug administration;
3. S(+)-ketamine and S(+)-norketamine plasma concentrations.
- Secondary outcome1. Visual Analogue Scale (VAS) to assess mood, alertness and calmness (Bond and Lader);
2. VAS to assess psychedelic effects (Bowdle);
3. VAS to assess heat pain stimulus.
- Timepoints2 study days with at least 3 days in between.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThe aim of the study is to investigate the influence of S(+)-ketamine on the resting state fMRI in healthy volunteers. The study consists of 2 study days on which the volunteers receives S(+)-ketamine on one study day and placebo on the other study day in a randomised fashion. Before, during and after the infusion fMRI scans are made to look at resting state networks. Also before, during and after infusion S(+)-ketamine and S(+)-norketamine plasma concentrations and pharmacodynamic measurements will be obtained until approximately 3 hours after the start of the infusion.
- Main changes (audit trail)
- RECORD12-aug-2010 - 21-sep-2010


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