Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers

This randomised controlled trial (n=70) investigated the effects of ketamine on mentalizing and metacognition in healthy volunteers.

Conducted by University Hospital, Bonn, the study aimed to understand if ketamine could induce difficulties in social cognition similar to those observed in people with schizophrenia. Participants were administered ketamine or a placebo intravenously while completing a mentalizing task in an fMRI scanner.

Primary outcome measures included changes in mentalizing/theory of mind and neural response to ketamine/placebo during social cognition. Secondary outcome measures included psychotic symptom load and metacognitive typology. The study enrolled 70 participants and was conducted from June 2019 to September 2020.

Topic Healthy Subjects
Compound Ketamine Placebo
Country Germany
Visit trial
Status Completed
Results Published No
Start date 15 June 2019
End date 27 September 2020
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 70
Sex All
Age 18- 35
Therapy No

Trial Details

Antipsychotic medication shows generally good effect sizes when looking at reduction of positive psychotic symptoms of schizophrenia, such as paranoia or delusion. However, social functioning often remains deficient in patients, meaning dopamine-receptor antagonists are not sufficient in treatment of people with schizophrenia. A naturalistic video-based paradigm, named MASC has been used in the past to model over- and undermentalizing in patients with autism spectrum disorder and schizophrenia, since deficits in mentalizing can be explained by either overinterpreting a social situation (e.g. paranoid thoughts about intentions of others towards self) or by lacking the skill to read intentions of others. To find out whether experimental manipulation via a non-competetive N-methyl-D-aspartate antagonist can induce difficulties with social cognition similar to those observed in people with schizophrenia, the investigators will conduct a RCT applying either ketamine or a placebo intravenously while participants are completing the above mentioned mentalizing task in the fMRI-scanner.

NCT Number NCT05320991

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.