Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression

Exclusion Criteria

• •1. Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes
• •2. Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry
• •3. Patients with body mass index (BMI) \< 18.5 kg/m² or \>35 kg/m²
• •4. History of serotonin syndrome events
• •5. History of seizures or use of anticonvulsant medication
• •6. Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation
• •7. Known symptomatic cardiovascular disease including structural abnormalities, moderate and severe hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), heart failure, myocardial infarction, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, potentially life-threatening arrhythmias and channelopathies (diseases caused by ion channel dysfunction)
• •8. Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder
• •9. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria
• •10. Diagnosis or family history of Tourette's syndrome or dystonia
• •11. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
• •12. Immunodeficiency disorders (e.g. organ transplantation, Human Immunodeficiency Virus (HIV) infection)
• •13. Known hypersensitivity to any of the ingredients of the trial medication, e.g. patients with known rare hereditary problems of fructose intolerance
• •14. Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index \<1 - e.g. contraceptive pill, intrauterine device (IUD)) during the study period (Screening to Follow-up)
• •15. Pregnancy and lactation
• •16. Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start
• •17. Patients who are institutionalised by court order or regulatory action
• •18. Patients, who are members of the staff of the trial centre, staff of the sponsor or involved Clinical Research Organisation (CRO), the investigator him- / herself or close relatives of the investigator
• •19. Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
• •20. Current use of and use within the last 2 weeks before inclusion due to possible interactions with stimulants or SSRIs/SNRIs and possible resulting or expected side effects:
• •1. Antipsychotics (such as chlorpromazine, haloperidol, thioridazine; except for quetiapine up to 100mg/day)
• •2. SSRIs and SNRIs daily doses of \>40 mg (es)citalopram, \>200 mg sertraline, \>300 mg venlafaxine extended release
• •3. Monoamine oxidase inhibitors (MAO) inhibitors
• •4. tricyclic antidepressants
• •5. benzodiazepines (including Z-drugs)
• •6. atypical antidepressants (with an exception for daily doses of 100-300 mg trazodone)
• •7. Dopamine reuptake inhibitors (special restriction for bupropion)
• •8. antiarrhythmics (Class IA and III)
• •9. antibiotics (in particular macrolides and fluoroquinolones, linezolid)
• •10. opioids
• •11. hydroxychloroquine, chloroquine
• •12. ketoconazole
• •13. acetylsalicylic acid (dose up to 300 mg allowed)
• •14. diphenhydramine
• •15. apixaban
• •16. metoprolol
• •17. pregabalin
• •18. budesonide / formoterol
• •19. albuterol / salbutamol