Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients

Medical University Of Vienna1 site in 1 country120 target enrollmentJanuary 15, 2025

Overview

Identifying reward-specific alterations in dopamine synthesis (PET) in the nucleus accumbens (NAcc) in patients with MDD compared to healthy volunteers applying the Monetary Incentive Delay Task
To assess the effect of two different antidepressant agents (escitalopram, bupropion) on reward consumption and reward-specific NAcc dopamine synthesis rates in patients with MDD in a longitudinal design
To assess the relationship between reward-specific NAcc dopamine synthesis and treatment response in MDD

Registry

euclinicaltrials.eu

Start Date

January 15, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sponsor

Responsible Party

Principal Investigator

Department of Psychiatry and Psychotherapy, Division of General Psychiatry

Scientific

Medical University Of Vienna

•Male and female subjects aged between 18-65 years of age
•Healthy subjects: HDRS29 ≤ 8, MADRS ≤ 6 and BDI-II < 13
•Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II
•Satisfactory general health as determined by past medical history, physical examination, vital signs at screening
•Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm
•Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-
•Sufficient visual and auditory performance for neuropsychological testing
•Written informed consent will be obtained prior to the start of any study procedures. Therefore, willingness and competence to sign the informed consent form is needed.
•Potential patients must be able to communicate well with the investigator and comply with the requirements of the study
•Only participants who are legally authorized to give informed consent will be included in the present study.

•Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
•Previous escitalopram- or bupropion intake
•Antidepressive trials wit DBS, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
•Current smoking, substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to DSM-IV
•Failure to comply with the study protocol or follow the instructions of the investigators
•Positive urine pregnancy test
•Known pregnancy or lactation
•MRI scan that shows evidence of stroke, infarct, or other space-occupying lesion or structural abnormality
•History of any other drug or alcohol abuse or misuse
•Participation in any clinical investigation within 12 weeks prior to dosing

Reward-specific changes of dopamin-synthesis

To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD
To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design
Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers