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The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

Primary Purpose

Major Depressive Disorder

Status

Recruiting

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

Ketamine

Placebo

About this trial

This is an interventional basic science trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ketamine first, then placebo

Placebo frist, then ketamine

Arm Description

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

0.9% NaCl, then ketamine

Outcomes

Primary Outcome Measures

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

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

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

Levels of pleasantness assessed during aesthetic fMRI task

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

Number of of chills assessed during aesthetic fMRI task

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05320107

First Posted

February 26, 2022

Last Updated

July 14, 2022

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT05320107

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamine first, then placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo frist, then ketamine

Arm Type

Experimental

Arm Description

0.9% NaCl, then ketamine

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0.9% NaCl

Primary Outcome Measure Information:

Title

BOLD signal assessed with fMRI during aesthetic paradigm

Description

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

Time Frame