Acute effects of ketamine, quantified with PET and radioligand

Phase 1

• Conditions: Acute effects of ketamine; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2022-003266-21-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-05
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigation of the acute effect of ketamine on the NMDA receptor using PET;Secondary Objective: Investigation of potential long-term effects on the NMDA receptor after ketamine administration ;Primary end point(s): Significant reduction of the volume distribution of the radioligand;Timepoint(s) of evaluation of this end point: Study session 1 and 2

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Investigate the alterations in GluN2B volume of distribution, depending on the time of placebo/ketamine administration;Timepoint(s) of evaluation of this end point: Study session 1 and 2