KETASELF-1

Linköpings Universitet

Linköping Campus US, Linköping, Sweden,

Markus Heilig, Linköpings Universitet, 0046 1036479, Markus.Heilig@liu.se

Markus Heilig, Linköpings Universitet, 0046 1036479, Markus.Heilig@liu.se

No

No

No

Final

17 Jan 2024

Yes

22 Nov 2022

Yes

25 Nov 2022

No

1. Psychophysical measure: Tactile detection threshold during self-touch will be lower during the ketamine- than during the placebo-session. 2. Neurophysiological measure: The difference between neural signatures of self-touch and other-touch will be smaller during the ketamine session than during the placebo-session.

To minimize the risks, only healthy volunteers were included in the study. The research subjects were required not to be pregnant or planning to become pregnant during study participation. For women of childbearing age, the use of a highly effective contraceptive was required throughout the study participation. All female research subjects also underwent pregnancy tests at visits 1, 3, and 4 to minimize the risk of fetal exposure to ketamine. Ketamine infusion Individuals with predisposing conditions such as respiratory diseases were excluded. During the MRI sessions when ketamine infusion was given, the participants were carefully monitored by a nurse and via physiological parameters. The study participants had access to an alarm button with which they could signal any problems to the study staff and were then allowed to leave the MR machine. Any adverse events were recorded at visits 3 and 4 and at follow-up telephone calls after both of these visits. MRI examination The study participants were provided with earplugs to protect them from the high noise level in the MRI. A research nurse was present at the experiment and provided subjects with detailed MRI safety information before entering the MRI room. The research nurse ensured that the participant did not enter the room with ferromagnetic metal objects on or inside the body. Intravenous catheterization The risks of intravenous catheterization were minimized with the help of experienced medical personnel who used sterile technique and took standard precautions. Integrity To minimize the risk of breach of privacy, the research subject was assigned a study code, and all samples and collected data were labeled with this code. All data were stored on computers that were password-protected and encrypted.

01 Feb 2021

No

Yes

Sweden: 30

30

30

0

0

0

0

0

0

30

0

0

main (overall period)

Randomised - controlled

The pharmacy prepared, based on the randomization list, an infusion bag containing ketamine or placebo. Both products looked identical and a blinded label was added on the bag. Randomization and blinding were insulated from any of the investigators and study staff.

Ketamine

Abcur 10mg/ml

Solution for solution for infusion

Intravenous drip use

0.5 mg*kg bodyweight per 40 min = 0.0125 mg*kg bodyweight per min

0.9% NaCl

Solution for infusion

Infusion

0.9% NaCl

main

ketamine

Primary

start-end

Inclusion - Follow-up phone call 2-3 days after last study visit

1

all subjects