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Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients
EU CTIS ID: 2024-518226-32-00
What this study is testing
- Identifying reward-specific alterations in dopamine synthesis (PET) in the nucleus accumbens (NAcc) in patients with Major Depressive Disorder (MDD) compared to healthy volunteers applying the Monetary Incentive Delay Task - To assess the effect of 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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 or ICD-10 diagnosis of MDD, Depressive Episode, or Recurrent Depressive Disorder 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 (body mass index) within 19-26. Exceptions might be made based on clinical impression (e.g., elevated BMI due to above-average muscle mass).
You likely can't join if
- Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
- Healthy controls: Therapy with any kind of psychotropic medication within the last 3 months
- Antidepressive trials with deep brain stimulation (DBS), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
- Current regular smoking, regular 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
See the full eligibility 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 or ICD-10 diagnosis of MDD, Depressive Episode, or Recurrent Depressive Disorder 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 (body mass index) within 19-26. Exceptions might be made based on clinical impression (e.g., elevated BMI due to above-average muscle mass).
- 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
- Healthy controls: Therapy with any kind of psychotropic medication within the last 3 months
- Antidepressive trials with deep brain stimulation (DBS), electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
- Current regular smoking, regular 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. Exceptions can be made, provided that the study was conducted under the supervision of Univ.-Prof. PD Dr. med. Rupert Lanzenberger and his study team, and that the preceding study did not involve any radiation exposure
- Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand
- Healthy controls: Any unstable / severe 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 severe atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, mirtazapine, carbidopa or entacapone)
- 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
- Depressed patients: Therapy with dopaminergic antidepressants including bupropion or other dopaminergic psychotropic agents (antipsychotics, stimulants, etc.) within the last 3 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.