The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320107
• Other study ID #: PSY-NIL-0010
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: Rupert Lanzenberger, MD
• Phone: 0043 1 40400
• Email: rupert.lanzenberger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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