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Unknown statusPhase 1

The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

NCT05320107 · Medical University of Vienna

Closed to entry
Status
Not accepting participants
Phase 1
Phase
60
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • BOLD signal assessed with fMRI during aesthetic paradigm

    Measured over Change from baseline to up to 4 weeks

  • BOLD signal assessed with fMRI during reward paradigm

    Measured over Change from baseline to up to 4 weeks

  • BOLD signal assessed with fMRI during sexual arousal paradigm

    Measured over Change from baseline to up to 4 weeks

  • Levels of pleasantness assessed during aesthetic fMRI task

    Measured over Change from baseline to up to 4 weeks

  • Number of of chills assessed during aesthetic fMRI task

    Measured over Change from baseline to up to 4 weeks

  • BOLD signal assessed with fMRI during resting state

    Measured over Change from baseline to up to 4 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 55 Years
Ages
All
Sex
Accepted
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

Where

1 study site

FacilityCityRegionCountry
Medical University of ViennaVienna—Austria

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05320107 on ClinicalTrials.gov →

Last updated in the registry 2024-04-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

All 7 trials from Medical University of Vienna →