Investigating dopamine changes in healthy and depressed individuals
Reward-specific Changes of Cerebral Dopamine Synthesis in Healthy Volunteers and Depressed Patients
PHASE4 · Medical University of Vienna · NCT06675851
This study is testing how two different antidepressants affect dopamine levels in the brains of people with depression compared to healthy individuals to better understand how depression works.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06675851 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of dopamine in major depressive disorder (MDD) by examining how common antidepressants affect dopamine synthesis in the brain. Using advanced imaging techniques like positron emission tomography (PET) and magnetic resonance imaging (MRI), the research will assess reward-specific changes in dopamine levels among depressed patients compared to healthy individuals. The study will involve administering two different antidepressants, Bupropion and Escitalopram, to evaluate their differential effects on the reward system. The findings could provide insights into the neurobiological mechanisms underlying depression and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 18-65 who have a DSM-IV diagnosis of major depressive disorder.
Not a fit: Patients with conditions outside the specified age range or those who do not meet the diagnostic criteria for major depressive disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with major depressive disorder by tailoring antidepressant therapies based on individual dopamine responses.
How similar studies have performed: Previous studies have indicated the importance of dopamine in depression, but this specific approach of examining reward-specific changes with different antidepressants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects aged between 18-65 years of age * 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 * Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease * 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 * Ingestion of antidepressants or other psychotropic agents within the last 6 months 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 * Significant radiation exposure (\>5 mSv) in the frame of participation in trials within the past 10 years
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Study coordinator: Rupert Lanzenberger, Univ.-Prof. Priv.-Doz. Dr.
- Email: rupert.lanzenberger@meduniwien.ac.at
- Phone: +43 1 40400 35760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, functional PET, PET/MRI, Reward, Bupropion, Escitalopram, MDD, Depression