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Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers (METAKETAII)

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ClinicalTrials.gov Identifier: NCT05320991
Recruitment Status : Completed
First Posted : April 11, 2022
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE March 14, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date April 18, 2022
Actual Study Start Date  ICMJE June 15, 2019
Actual Primary Completion Date September 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
  • Changes in Mentalizing/Theory of Mind [ Time Frame: During ketamine/placebo application in MRI ]
    Over- and undermentalizing as characterized by the Movie for the assessment of social cognition (MASC). Higher scores on the "Mentalizing"-scale indicate better performance. Scores are divded between 4 scales (Mentalizing, No Mentalizing, Overmentalizing, Undermentalizing), each ranging from 0 to 27. Higher scores in one of the scales pertaining to "no Mentalizing, Overmentalizing or Undermentalizing mean a deficiency in mentalizing skills.
  • Neural response to ketamine/placebo during social cognition [ Time Frame: During ketamine/placebo application in MRI ]
    fMRI imaging will be performed to measure blood oxygen level-dependent (BOLD) signal in response to mentalizing cues in the MASC-task under ketamine/placebo. BOLD-signal will be measured with T2-weighted images in a 3T MRI. Data will be analyzed using SPM 12 in MATLAB. Deviations in BOLD-activity under ketamine compared to placebo (higher or lower activity of certain voxels/clusters compared all other voxels in the brain) will mean a change in neural response due to the effect of the substance
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Changes in Mentalizing/Theory of Mind [ Time Frame: During ketamine/placebo application in MRI ]
    Over- and undermentalizing as characterized by the Movie for the assessment of social cognition (MASC). Higher scores on the "Mentalizing"-scale indicate better performance.
  • Neural response to ketamine/placebo during social cognition [ Time Frame: During ketamine/placebo application in MRI ]
    fMRI imaging will be performed to measure blood oxygen level-dependent signal in response to mentalizing cues in the MASC-task.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2022)
  • Psychotic symptom load in PANSS-Questionnaire [ Time Frame: 10 minutes after cessation of MRI and ketamine/placebo application ]
    Positive and negative symptoms measured with questionnaire used in schizophrenia-research (Positive and Negative Symptom Scale). The PANSS uses a scale ranging from 1 to 7 in three different subscales (positive, 7 items; negative, 7 items; disorganized, 16 items). Higher numbers mean more psychotic symptoms.
  • Metacognitive-Questionnaire (MCQ) [ Time Frame: 20 minutes after cessation of MRI and ketamine/placebo application ]
    Metacognitive typology as assessed with the MCQ. The MCQ is a questionnaire containing 30 items, based on a 4-point Likert scale (dont agree - strongly agree) from 1 to 4. It measures metacognitive ability in 5 subscales, each containing 6 items (Uncontrollability and Danger, Cognitive Self-Consciousness, Need to control thoughts, Positive Beliefs, Cognitive Confidence). This is a short form of the widely used Metacognitions Questionnaire that measures individual differences in a selection of metacognitive judgments and monitoring tendencies considered important in the metacognitive model of psychological disorders
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2022)
  • Psychotic symptom load in PANSS-Questionnaire [ Time Frame: 10 minutes after cessation of MRI and ketamine/placebo application ]
    Positive and negative symptoms measured with questionnaire used in schizophrenia-research (Positive and Negative Symptom Scale)
  • Metacognitive-Questionnaire (MCQ) [ Time Frame: 20 minutes after cessation of MRI and ketamine/placebo application ]
    Metacognitive typology as assessed with the MCQ
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers
Official Title  ICMJE A Randomized Control Trial Employing fMRI to Investigate the Effects of Ketamine on Mentalizing and Metacognition in Healthy Volunteers
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
All investigators (except anesthesiologists) are blinded until fMRI data has been preprocessed
Primary Purpose: Basic Science
Condition  ICMJE
  • Ketamine-Induced Psychotic Disorder
  • Social Cognition
  • Theory of Mind
Intervention  ICMJE
  • Drug: 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.
  • Drug: 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).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants receive a saline-solution intravenously
    Intervention: Drug: Nacl 0.9%
  • Experimental: Ketamine
    Participants receive ketamine (Plasma-level 100 ng/ml with an initial bolus administered as a 2 mg/ml solution)
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2022)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 27, 2020
Actual Primary Completion Date September 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Potential participants are excluded based on the following criteria:

  • history of psychiatric/neurological disorder (self and first-degree relatives)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05320991
Other Study ID Numbers  ICMJE #19-03-29 (METAKETA)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rene Hurlemann, University Hospital, Bonn
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bonn
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bonn
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP