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The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

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ClinicalTrials.gov Identifier: NCT05320107
Recruitment Status : Not yet recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE February 26, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date April 11, 2022
Estimated Study Start Date  ICMJE April 1, 2022
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
  • BOLD signal assessed with fMRI during aesthetic paradigm [ Time Frame: Change from baseline to up to 4 weeks ]
    Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during an aesthetic processing task
  • BOLD signal assessed with fMRI during reward paradigm [ Time Frame: Change from baseline to up to 4 weeks ]
    Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a reward processing task
  • BOLD signal assessed with fMRI during sexual arousal paradigm [ Time Frame: Change from baseline to up to 4 weeks ]
    Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during a sexual arousal paradigm
  • Levels of pleasantness assessed during aesthetic fMRI task [ Time Frame: Change from baseline to up to 4 weeks ]
    Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task
  • Number of of chills assessed during aesthetic fMRI task [ Time Frame: Change from baseline to up to 4 weeks ]
    Number of chills in response to aesthetic stimuli during aesthetic paradigm task
  • BOLD signal assessed with fMRI during resting state [ Time Frame: Change from baseline to up to 4 weeks ]
    Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects
Official Title  ICMJE Unraveling the Aesthetic Mind in Anhedonia, Insights From Pharmacological Imaging of the Human Brain: A Single-blind, Randomized, Placebo-controlled Cross-over Study
Brief Summary The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia. To address this aim, 25 patients with major depressive disorder and 35 healthy controls will be assessed twice with magnetic resonance imaging, once after administration of intravenous ketamine (subanesthetic dose) and once after administration of placebo.This study has a single-center, placebo-controlled, cross-over study design. During MRI, structural, resting state, and functional imaging will be performed. Functional imaging will comprise aesthetic processing, reward, and sexual arousal paradigms. In addition, various neuropsychological scales assessing depressive symptoms, anhedonia, and aesthetic processing will be performed. Eligibility for participation will be assessed during a screening visit, a follow up visit will end study participation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Ketamine
    0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study
  • Drug: Placebo
    0.9% NaCl
Study Arms  ICMJE
  • Experimental: Ketamine first, then placebo
    0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
  • Experimental: Placebo frist, then ketamine
    0.9% NaCl, then ketamine
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2025
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • General health based on medical history and physical examination
  • Psychiatric health based on structured clinical interview for DSM-5 (SCID) for healthy controls
  • Major depressive episode (first or recurrent) based on structured clinical interview for DSM-5 and ICD-10 for patients
  • Age 18 to 55 years
  • Right-handedness (due to potential lateralization effects of lefthanded subjects)
  • Willingness and competence to sign the informed consent form

Exclusion Criteria:

  • Current or history of neurological disease
  • Current medical illness requiring treatment
  • Psychiatric diagnosis for healthy individuals
  • Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals
  • Pregnancy or current breastfeeding
  • Current or former substance abuse
  • Previous ketamine use in lifetime
  • Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
  • Failure to comply with the study protocol or to follow the instruction of the investigating team
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rupert Lanzenberger, MD 0043 1 40400 ext 35760 rupert.lanzenberger@meduniwien.ac.at
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05320107
Other Study ID Numbers  ICMJE PSY-NIL-0010
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 Not Provided
Current Responsible Party Rupert Lanzenberger, Medical University of Vienna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medical University of Vienna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date April 2022

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