drugset / Trial / NCT05320991

Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers

NCT05320991 ↗

Phase 4 Completed 70 enrolled University Hospital, Bonn
RandomizedParallel-groupTriple-blindBasic science

Summary

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.

Timeline

Start
2019-06-15
Primary completion
2020-09-27
Completion
2020-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule — Intravenous