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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05320107
Other study ID # PSY-NIL-0010
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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