The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

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

Tracking Information

• First Submitted Date: February 26, 2022
• First Posted Date: April 11, 2022
• Last Update Posted Date: April 11, 2022
• Estimated Study Start Date: April 1, 2022
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Major Depressive Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 8, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 28, 2025
• Estimated Primary Completion Date: February 28, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Rupert Lanzenberger, MD; 0043 1 40400 ext 35760; rupert.lanzenberger@meduniwien.ac.at

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05320107
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Rupert Lanzenberger, Medical University of Vienna
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical University of Vienna
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medical University of Vienna
• Verification Date: April 2022