Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers
NCT ID: NCT05320991
Last Updated: 2022-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2019-06-15
2020-09-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Participants receive a saline-solution intravenously
Nacl 0.9%
Saline solution will also be applied with the Graseby 3500 intravenous infusion pump controlled by the STANPUMP software (Steven Shafer, M.D., Anesthesiology Service, PAVAMC 3801 Miranda Ave., Palo Alto, USA).
Ketamine
Participants receive ketamine (Plasma-level 100 ng/ml with an initial bolus administered as a 2 mg/ml solution)
Ketamine
Ketamine is applied with a Graseby 3500 intravenous infusion pump controlled by the STANPUMP software (Steven Shafer, M.D., Anesthesiology Service, PAVAMC 3801 Miranda Ave., Palo Alto, USA). Target plasma levels are 100 ng/ml with an initial bolus administered as a 2 mg/ml solution.
Interventions
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Ketamine
Ketamine is applied with a Graseby 3500 intravenous infusion pump controlled by the STANPUMP software (Steven Shafer, M.D., Anesthesiology Service, PAVAMC 3801 Miranda Ave., Palo Alto, USA). Target plasma levels are 100 ng/ml with an initial bolus administered as a 2 mg/ml solution.
Nacl 0.9%
Saline solution will also be applied with the Graseby 3500 intravenous infusion pump controlled by the STANPUMP software (Steven Shafer, M.D., Anesthesiology Service, PAVAMC 3801 Miranda Ave., Palo Alto, USA).
Eligibility Criteria
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Exclusion Criteria
* learning disabilities, or loss of consciousness for more than 5 minutes
* history of alcohol or drug abuse within the last 12 months
* history of ketamine abuse
* history of complications during anesthesia (self and first-degree relatives)
* serious physical illness
* claustrophobia
* color-blindness
* metalliferous implant
* visual impairments other than corrective lenses
* injury or disease of the inner ear with loss of hearing
* consumption of any prescription or over-the-counter medication 3 days previous to the examination
* pregnancy
* currently breastfeeding a baby
* hypotension (blood pressure \< 100/60)
* hypertension (blood pressure \> 140/90)
* underweight (BMI \<17)
* overweight (BMI ≥30)
Recruited participants are required to meet the following criteria:
* height between 150 and 195 cm
* bodyweight between 50 and 99kg
* male or female
* right-handed
* physically, neurologically and psychiatrically healthy
* non-smoker
* normal or corrected-to-normal eye-sight
* good command of German language
18 Years
35 Years
ALL
Yes
Sponsors
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University Hospital, Bonn
OTHER
Responsible Party
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Rene Hurlemann
Professor for Psychiatry
Locations
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Department of Psychiatry and Psychotherapy, University Hospital Bonn
Bonn, , Germany
Countries
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Related Links
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Other Identifiers
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#19-03-29 (METAKETA)
Identifier Type: -
Identifier Source: org_study_id
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