Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients
- Conditions
- Major Depression
- Registration Number
- 2024-518226-32-00
- Lead Sponsor
- Medical University Of Vienna
- Brief Summary
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 19-26.
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
Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand
Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease
Significant radiation exposure (>5 mSv) in the frame of participation in trials within the past 10 years
Presence of psychotic symptoms
Acute suicidality
Any contraindication for magnetic resonance or PET imaging
Presence of any metallic implant in the head
History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, escitalopram)
Other clinically significant abnormality on physical, neurological, or laboratory examination or on electrocardiogram (ECG) that, in the opinion of the investigator precludes the patient from the study
Prior therapy with antidepressants or other psychotropic agents (depressed patients: ingestion of antidepressants or other psychotropic agents within the last 6 months)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reward-specific changes of dopamin-synthesis Reward-specific changes of dopamin-synthesis
- Secondary Outcome Measures
Name Time Method To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD 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 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 Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers
Trial Locations
- Locations (1)
Medical University Of Vienna
🇦🇹Vienna, Austria
Medical University Of Vienna🇦🇹Vienna, AustriaGodber Mathis GodbersenSite contact+436642059337godber.godbersen@meduniwien.ac.at