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

Phase 4

Recruiting

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

Inclusion Criteria

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.

Exclusion Criteria

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, Austria
Godber Mathis Godbersen
Site contact
+436642059337
godber.godbersen@meduniwien.ac.at