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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.

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. - The F-KET Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34353
Enrollment
12
Registered
2010-09-15
Start date
2011-03-29
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

fMRI onderzoek in gezonde vrijwilligers not applicable

Interventions

Intravenous infusion of S(+)-ketamine at 20 mg/70 kg/hr for 1 hour, thereafter 40 mg/70 kg/hr for 1 hour, or an infusion with NaCl 0,9%.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy volunteers age 18-45 right handed naive to Ketanest-S

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
resting state network (fMRI)

Secondary

MeasureTime frame
arterial spin labeling (fMRI) plasma concentrations of S(+)-ketamine and S(+)-norketamine pain relief side effects

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)