E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute effects of ketamine |
Akute Effekte von Ketamin |
|
E.1.1.1 | Medical condition in easily understood language |
Acute effects of ketamine |
Akute Effekte von Ketamin |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigation of the acute effect of ketamine on the NMDA receptor using PET |
Untersuchung der akuten Wirkung von Ketamin auf den NMDA-Rezeptor mittels PET |
|
E.2.2 | Secondary objectives of the trial |
Investigation of potential long-term effects on the NMDA receptor after ketamine administration |
Untersuchung möglicher Langzeitwirkungen auf den NMDA-Rezeptor nach Ketamin-Verabreichung |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- General health based on medical history, physical examination and structured clinical interview for DSM‐V (SCID) - Age 18 to 55 years - Willingness and competence to sign the informed consent form
|
- Allgemeiner Gesundheitszustand auf der Grundlage von Anamnese, körperlicher Untersuchung und strukturiertem klinischen Interview nach DSM-V (SCID) - Alter zwischen 18 und 55 Jahren - Bereitschaft und Fähigkeit, die Einwilligungserklärung zu unterschreiben
|
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E.4 | Principal exclusion criteria |
- Current or history of psychiatric or neurological disease - Current medical illness requiring treatment - Current or former psychopharmacological treatment - Pregnancy or currently breastfeeding - Current or former substance abuse - Any contraindication for MRI e.g. (implants, stainless steel graft) - Failure to comply with the study protocol or to follow the instruction of the investigating team - If the radiation exposure by PET or SPECT or CT during scientific study participation in the last 10 years exceeds 30 mSv
|
- Aktuelle oder frühere psychiatrische oder neurologische Erkrankungen - Derzeitige behandlungsbedürftige medizinische Erkrankung - Gegenwärtige oder frühere psychopharmakologische Behandlung - Schwangerschaft oder derzeitiges Stillen - Aktueller oder früherer Drogenmissbrauch - Jede Kontraindikation für MRT, z. B. (Implantate, Edelstahltransplantate) - Nichteinhaltung des Studienprotokolls oder Nichteinhaltung der Anweisungen des Untersuchungsteams - Wenn die Strahlenbelastung durch PET, SPECT oder CT während der Teilnahme an einer wissenschaftlichen Studie in den letzten 10 Jahren 30 mSv übersteigt |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Significant reduction of the volume distribution of the radioligand |
Signifikante Verringerung der Volumenverteilung des Radioliganden |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study session 1 and 2 |
Untersuchungstag 1 und 2 |
|
E.5.2 | Secondary end point(s) |
Investigate the alterations in GluN2B volume of distribution, depending on the time of placebo/ketamine administration |
Untersuchung der Veränderungen des Verteilungsvolumens von GluN2B in Abhängigkeit vom Zeitpunkt der Verabreichung von Placebo/Ketamin |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study session 1 and 2 |
Untersuchungstag 1 und 2 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Neuroscience |
Neurowissenschaftlich |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit last subject |
Letzte Visite letzte Teilnehmer:in |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |