The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

NCT05320107 | Recruiting Phase 1

• 1 other identifier: PSY-NIL-0010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (6)

• BOLD signal assessed with fMRI during aesthetic paradigm

  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

  Change from baseline to up to 4 weeks

• BOLD signal assessed with fMRI during reward paradigm

  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

  Change from baseline to up to 4 weeks

• BOLD signal assessed with fMRI during sexual arousal paradigm

  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

  Change from baseline to up to 4 weeks

• Levels of pleasantness assessed during aesthetic fMRI task

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

  Change from baseline to up to 4 weeks

• Number of of chills assessed during aesthetic fMRI task

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

  Change from baseline to up to 4 weeks

• BOLD signal assessed with fMRI during resting state

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

  Change from baseline to up to 4 weeks

Study Arms (2)

Ketamine first, then placebo

EXPERIMENTAL

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

Drug: Ketamine; Drug: Placebo

Placebo frist, then ketamine

EXPERIMENTAL

0.9% NaCl, then ketamine

Drug: Ketamine; Drug: Placebo

Interventions

Ketamine DRUG

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

Ketamine first, then placebo; Placebo frist, then ketamine

Placebo DRUG

0.9% NaCl

Ketamine first, then placebo; Placebo frist, then ketamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Rupert Lanzenberger, MD

CONTACT

0043 1 40400; rupert.lanzenberger@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: April 11, 2022
• Study Start: June 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

AU (1)