The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study
  • Placebo (DRUG)
    0.9% NaCl

Condition or Disease

  • Major Depressive Disorder

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 60 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Jun 01, 2022 ACTUAL
    Primary Completion: Feb 28, 2025 ESTIMATED
    Completion Date: Feb 28, 2025 ESTIMATED
    Study First Posted: Apr 11, 2022 ACTUAL
    Last Updated: Jul 14, 2022

    Sponsors / Collaborators

    Lead Sponsor: Medical University of Vienna
    Responsible Party: N/A

    Participant Groups

    • 0.5mg/kg bodyweight (or 0.25mg/kg bodyweight) ketamine, will be determined in pilot study, then placebo

    • 0.9% NaCl, then ketamine

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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

    • 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

    • 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

    • Level of pleasantness (Numbered scale) of aesthetic stimuli during aesthetic paradigm task

    • Number of chills in response to aesthetic stimuli during aesthetic paradigm task

    • Difference in Blood Oxygen Level Dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) between ketamine and placebo condition during resting state

    More Details

    NCT Number: NCT05320107
    Other IDs: PSY-NIL-0010
    Study URL: https://clinicaltrials.gov/study/NCT05320107
    Last updated: Sep 29, 2023