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New treatment option for Major Depressive Disorder (MDD)
Official title Reward-specific Changes of the Chemical Messenger Dopamine in the Brain of Healthy and Depressed People
ClinicalTrials.gov ID: NCT06675851
What this study is testing
What is WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline?
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline is an investigational medicine, given as an once-daily, being studied as a potential treatment for major depressive disorder (mdd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male and female people 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...
- people must weigh 50-100 kg to participate in this study with a BMI within 19-26.
You likely can't join if
- 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
See the full eligibility criteria
- Male and female people 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...
- people 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
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 study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.