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

Inclusion Criteria:

1. Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 (fifth version of Diagnostic and Statistical Manual of Mental Disorders) or ICD (International Statistical Classification Of Diseases And Related Health Problems)guidelines) which started in childhood (at the age of <12 years)

2. Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 atbaseline (Visit (V) 0)

3. Moderate to severe depression according to ICD-10 (depressive episode: Code F32;recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg DepressionRating Scale (MADRS) score of >20 at baseline (V0)

4. CGI-S ≥ 4 at baseline (V0)

5. Patients receiving selective serotonin reuptake inhibitors (SSRIs) orSerotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the last 2weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mgvenlafaxine extended release)

6. Male or female patients ≥ 18 years and ≤ 65 at time of enrolment

7. Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms infemales)

8. Patient is either free of stimulant medication or who, after discussion with his /her treating physician, is able and willing to discontinue the current psychotropicmedication(s) for treatment of ADHD symptoms (specifically, methylphenidate,lisdexamfetamine, guanfacine or atomoxetine or any other medication approved for thetreatment of ADHD) ) for the duration of the study, as well as is able and willingto discontinue all relevant co-medication according to exclusion criterion no. 20a-sfor comorbid conditions during the clinical trial, if applicable

9. Written informed consent and data protection declaration obtained prior to theinitiation of any protocol required procedures

10. Willing and able to comply to study procedures and study protocol

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 ofclinical 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 mayinterfere with trial participation

7. Known symptomatic cardiovascular disease including structural abnormalities,moderate and severe hypertension (systolic blood pressure ≥160 mmHg, diastolic bloodpressure ≥100 mmHg), heart failure, myocardial infarction, arterial occlusivedisease, 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, vascularabnormalities 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 effectivecontraception (defined as PEARL index <1 - e.g. contraceptive pill, intrauterinedevice (IUD)) during the study period (Screening to Follow-up)

15. Pregnancy and lactation

16. Participation in another interventional clinical trial during the trial and withinthe 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 orinvolved Clinical Research Organisation (CRO), the investigator him- / herself orclose relatives of the investigator

19. Legal incapacity and/ or other circumstances rendering the patient unable tounderstand 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 possibleinteractions with stimulants or SSRIs/SNRIs and possible resulting or expected sideeffects:

21. Antipsychotics (such as chlorpromazine, haloperidol, thioridazine; except forquetiapine up to 100mg/day)

22. SSRIs and SNRIs daily doses of >40 mg (es)citalopram, >200 mg sertraline, >300mg venlafaxine extended release

23. Monoamine oxidase inhibitors (MAO) inhibitors

24. tricyclic antidepressants

25. benzodiazepines (including Z-drugs)

26. atypical antidepressants (with an exception for daily doses of 100-300 mgtrazodone)

27. Dopamine reuptake inhibitors (special restriction for bupropion)

28. antiarrhythmics (Class IA and III)

29. antibiotics (in particular macrolides and fluoroquinolones, linezolid)

30. opioids

31. hydroxychloroquine, chloroquine

32. ketoconazole

33. acetylsalicylic acid (dose up to 300 mg allowed)

34. diphenhydramine

35. apixaban

36. metoprolol

37. pregabalin

38. budesonide / formoterol

39. albuterol / salbutamol