Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06675851
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06675851
Study Brief:
Protocol Section:
NCT06675851