Psychosis
Conditions
Interventions
Group 1: s-Ketamine (K+) arm: Continuous intravenous infusion of s-ketamine HCl (0.1 mg/kg/h) during fMRI. Participants perform a perceptual decision-making task, followed by resting-state and localiz
Sponsors
Universitäre Psychiatrische Kliniken Basel
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to adhere to the study protocol and sign the consent form 2. Capability to give informed consent as evidenced by the ability to understand the purpose, risks and benefits of the study 3. = 18 and = 65 years of age at Screening 4. Body mass index 18-29 5. Fluent understanding of German 6. Normal or corrected-to-normal vision 7. Willingness to not operate a traffic vehicle or heavy machinery 24 hours after substance administration 8. Willingness to refrain from taking illicit psychoactive substances, including cannabis, for the duration of the study 9. Willingness to not consume more than one alcoholic standard drink the night before the study sessions and not consume alcohol for 24 h after each study session 10. Willingness to abstain from xanthine-based liquids 12 hours prior to the study sessions and during the sessions 11. Willingness to use effective birth-control throughout the study duration
Exclusion criteria
Exclusion criteria: 1. Women that are pregnant, nursing, or planning to become pregnant during the study period 2. Any irremovable magnetic materials such as metal pieces of implants (e.g., from surgeries, dental replacements, tattoos or accidents) 3. History of claustrophobia 4. Current use of psychoactive medications or illicit drugs 5. Consumption of >20 alcoholic standard drinks per week 6. Consumption of >5 cigarettes per day 7. Severe chronic or acute medical condition 8. Tachycardia >100 bpm and/or QTc time >430 ms, checked by electrocardiogram (ECG) at Screening 9. Hypertension (>140/90 mmHg) or hypotension (<85mmHg systolic) 10. Current or lifetime major mental health disorder 11. Personal or family (first-degree) history of a primary psychotic disorder 12. Recent (<30 days) or current participation in another clinical trial with pharmacological treatment 13. Refusal to be informed about potential incidental findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dependence of fMRI activity patterns in visual cortex on preceding perceptual choices under s-ketamine vs. placebo; analysis using logistic regression beta estimates from multivariate pattern analysis (V1); measured during both 60-minute fMRI sessions at least seven days apart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of preceding on current perceptual choices under s-ketamine vs. placebo; behavioral measure via logistic regression; assessed during both 60-minute fMRI sessions at least seven days apart. Correlation between the effect of preceding perceptual choices on fMRI activity and subjective psychosis-like experiences under s-ketamine; assessed with the 5D-ASC scale; across full session (approx. 3.5–4 h) including fMRI and post-session assessments. Correlation between the effect of preceding on current perceptual choices and psychosis-like experiences under s-ketamine; assessed with the 5D-ASC scale; across full session (approx. 3.5–4 h) including fMRI and post-session assessments. Changes in resting-state network activity under s-ketamine vs. placebo; resting-state fMRI after task-based fMRI; during the last 8–10 minutes of each session. | — |
Countries
Switzerland
Contacts
Public ContactPhilipp Sterzer
Universitäre Psychiatrische Kliniken Basel
Outcome results
None listed