The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects

NCT ID: NCT05320107

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Ketamine first, then placebo

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

0.9% NaCl

Placebo frist, then ketamine

0.9% NaCl, then ketamine

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

0.9% NaCl

Interventions

Ketamine

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

Intervention Type: DRUG

Placebo

0.9% NaCl

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Lanzenberger

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Rupert Lanzenberger, MD

Role: CONTACT

rupert.lanzenberger@meduniwien.ac.at

0043 1 40400 ext. 35760

Facility Contacts

Rupert Lanzenberger, MD

Role: primary

Other Identifiers

PSY-NIL-0010

Identifier Type: -

Identifier Source: org_study_id