A prospective, multicentre, randomised, double-dummy, double-blind, placebo-controlled 3-way Phase III study to investigate the efficacy and safety of two dexamfetamine sulfate formulations in adults with ADHD - DEXINA -

Ki vehet részt

• Signed informed consent and data protection declaration prior to initiation of any trial procedures
• Male or female adult patient ≥18 years of age at time of enrolment
• Diagnosis of attention deficit / hyperactivity disorder (ADHD) based on a detailed psychiatric evaluation using a validated semi-structured interview tool (i.e. Wender-Reimherr Adult Attention Deficit Disorder Scale [WRAADDS], German Version: Wender-Reimherr Interview [WRI] or equivalent) a) in patients with no diagnosis based on a detailed psychiatric evaluation using a validated semi-structured interview tool and b) in patients diagnosed via a validated semi-structured interview tool such as WRI longer than 12 month ago
• Confirmation of onset of ADHD in childhood (at the age of <12 years) using the WURS-k questionnaire for retrospective assessment
• Patient has a minimum ADHS-DC-Q total score of 32 at Screening (Visit -2)
• Patient has a minimum CGI-S score of 4 at Screening (Visit -2)

Ki nem vehet részt

• Women of child-bearing potential who do not use a highly effective method of contraception (at least 4 weeks prior study), that is the case when the Pearl Index of the contraceptive measure is ≥1, Women who are in a homosexual relationship and women without a relationship/partner do not have to use a highly effective contraception method unless they have heterosexual sex
• Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start
• A history or presence of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2 receptor blockers, proton pump inhibitors or in antacid therapy
• History or Presence (6 months prior to Visit -2) of suicidal ideation (e.g. type 4 or type 5 according to Columbia Suicide Severity Rating Scale [C-SSRS])
• Known previous non-response to dexamfetamine sulfate
• Newly initiated behavioural, cognitive or cognitive-behavioural therapy or change in frequency of sessions within 3 months prior to Visit 0 (except for ADHD coaching which is no psychotherapy)
• Positive urine drug test at Visit -2 and, if applicable, also at Visit -1 (except for patients taking bupropion)
• Use of prohibited co-medication within 14 days prior to Visit 0: anticonvulsants, benzodiazepines, psychostimulants other than the IMP, antipsychotics, monoamine oxidase (MAO) inhibitors, lithium, guanfacine, clonidine, systemically administered ephedrine and pseudoephedrine, amantadine, coumarins, phenylbutazone, antacids and proton pump inhibitors
• Change of antidepressants including bupropion due to psychiatric condition within 3 months prior to Visit 0
• A History or presence of inflammatory bowel disease (IBD); Crohn's disease in particular can lead to an altered absorption of active pharmaceutical ingredients
• Diagnosis or family history of Tourette's syndrome or dystonia (Tic disorders (F95) and dystonias (G24), if they are associated with functional impairments
• Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
• Any severe psychiatric condition that requires medication
• Immunodeficiency disorders (e.g., organ transplantation, HIV infection)
• Pre-existing cardiovascular disorders including moderate and severe hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), heart failure, myocardial infarction, etc
• History or presence of severe depression, history or presence of anorexia nervosa / anorectic disorders, psychotic symptoms, severe affective disorders, schizophrenia, mania, psychopathic / borderline personality disorders
• A history of alcohol abuse or substance abuse disorder (exclusively nicotine abuse)
• Bariatric surgery (also known as metabolic surgery or weight loss surgery) is a surgical procedure used to manage obesity and obesity-related conditions as these conditions could have a negative impact on the retardation of the study medication
• History of serotonin syndrome events
• Any severe psychiatric condition that requires medication
• Pre-existing cardiovascular disorders), heart failure, myocardial infarction, peripheral occlusive disease, angina pectoris, haemodynamically significant congenital heart defects, cardiomyopathies, potentially life-threatening arrhythmias and channelopathies (diseases caused by ion channel dysfunction)
• Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg, or the presence of hypertension without appropriate antihypertensive medication, regardless of current blood pressure values
• Significant hepatic, gastrointestinal, renal, haematological or oncologic disorder
• Known hypersensitivity to any of the ingredients of the trial medication (Patients with the rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency) or known hypersensitivity or idiosyncrasy to sympathomimetic amines
• Pregnancy and lactation
• Patients who are institutionalised by court order or regulatory action
• 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
• Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
• Known to be or suspected of being unable to comply with the clinical trial protocol
• Diagnosis of current glaucoma, hyperthyroidism, pheochromocytoma or porphyria