This study investigates healthy participants to explore the effects of pharmacological interventions on dynamic networks. The findings are intended to contribute to the development of new personalized treatment approaches for psychiatric disorders in the long term
Conditions
Interventions
Group 1: Esketamine
Esketamine is administered intranasally using a intranasal mucosal atmoization device (LMA-7300-MAD). It will be administered in five individual doses of 0.2 ml each, with an inter
Sponsors
Universitätsklinikum Frankfurt am Main (Klinik für Psychatrie, Psychosomatik und Psychotherapie)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - no contraindications for MRI - psychological and physiological health (as specified by the exclusion criteria)
Exclusion criteria
Exclusion criteria: - Psychiatric disorders (diagnosed using the MINI) - Intolerance to the administered medications (Esketamine & Midazolam) - Regular or acute medication use - MRI-relevant metal implants or devices (e.g., pacemakers, prosthetics, intrauterine devices unless explicitly MRI-compatible, etc.) - Recent tattoos, tattoos with metallic ink, or permanent makeup - Medical contraindications for Ketamine intervention (e.g., glaucoma, renal failure, liver dysfunction, hyperthyroidism, past or acute cardiomyopathy, hypertension) - Medical contraindications for Midazolam intervention (e.g., chronic respiratory, renal, or heart failure, liver dysfunction, use of opioids or other benzodiazepines) - Pregnancy - History of ketamine abuse - History or elevated risk of psychosis - Insufficient German language proficiency - Severe hearing impairments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Changes in the metastability of neural networks - Differences in functional connectivity between placebo and active treatment during rest and task-based conditions (fMRI, EEG) - Correlations between neural network changes (fMRI, EEG) and behavioral data (EMA) fMRI and EEG measurements will take place right after intervention while the participants are under the influence of the substances. EMA measurements will start 3 days before the day of the intervention and will span over a duration of 9 days (including the intervention day). There is no follow-up measurement planned. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Accuracy and reaction times in the n-back and MID tasks - Content-related (e.g., verbosity, sentence length, scope) and acoustic (e.g., pitch, speech rate, volume) analysis of speech data to complement EMA data - Correlation between GPT-2 layer activations (particularly Layer 8) and neural activity patterns in fMRI during the processing of a narrative stimulus - Analysis of participants' subjective perception of the administered substance fMRI and EEG measurements will take place right after intervention while the participants are under the influence of the substances. EMA measurements will start 3 days before the day of the intervention and will span over a duration of 9 days (including the intervention day). There is no follow-up measurement planned. | — |
Countries
Germany
Contacts
Public ContactOliver Grimm
Universitätsklinikum Frankfurt am Main (Klinik für Psychatrie, Psychosomatik und Psychotherapie)
Outcome results
None listed