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NCT05320991: METAKETAII
Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers
Phase 4 trial testing Ketamine in Ketamine-Induced Psychotic Disorder in 70 participants. Completed in 27 September 2020.
27 September 2020
Quick facts
| Lead sponsor | University Hospital, Bonn |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 70 |
| Start date | 15 June 2019 |
| Primary completion | 27 September 2020 |
| Estimated completion | 27 September 2020 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Ketamine (ketamine) — full drug profile →
- Nacl 0.9%
Conditions studied
- Ketamine-Induced Psychotic Disorder — all drugs for Ketamine-Induced Psychotic Disorder →
- Social Cognition — all drugs for Social Cognition →
- Theory of Mind — all drugs for Theory of Mind →
Sponsor
University Hospital, Bonn
Who can join
Adults 18 to 35, any sex, with Ketamine-Induced Psychotic Disorder or Social Cognition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05320991
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Bonn trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05320991 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bonn
- Last refreshed: 18 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05320991.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing