The F-KET study.

A 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23425

Enrollment

Registered

2010-08-12

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

(psychomimetic) side effects, S(+)-ketamine, resting state fMRI, healthy volunteers (psychomimetische) bijwerkingen, S(+)-ketamine, resting state fMRI, gezonde vrijwilligers

Interventions

The 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 intrave

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male; 2. Right handed subjects; 3. Naive to ketamine; 4. Between 18 to 45 years of age.

Exclusion criteria

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; 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.

Design outcomes

Primary

Measure	Time frame
1. 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

Measure	Time frame
1. 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.	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)