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

Phase 1

Recruiting

Conditions: Patients with ADHD (according to ICD-10 / DSM-5)
Therapeutic area: Psychiatry and Psychology [F] - Psychological Phenomena [F02]
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2022-502903-31-00

Lead Sponsor: Medice Arzneimittel Puetter GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 303

Inclusion Criteria

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)

Exclusion Criteria

History of presence of severe depression, anorexia nervosa / anorectic disorders, psychotic symptoms, severe affective disorders, schizophrenia, mania, psychopathic / borderline personality disorders, Women of child-bearing potential who do not use a highly effective method of contraception, that is the case when the Pearl Index of the contraceptive measure is =1, Pregnancy and lactation, Presence or history (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]), Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start, 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, 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, Known previous non-response to dexamfetamine sulfate, Any severe psychiatric condition that requires medication, Newly initiated behavioural, cognitive or cognitive-behavioural therapy or change in frequency of sessions within 3 months prior to Visit 0, A current or recent diagnosis of substance abuse disorder (exclusively nicotine abuse) within the last 6 months of clinical trial entry according to investigator’s assessment, Positive urine drug test at Visit -2 and, if applicable, also at Visit -1, Patients with body mass index (BMI) <18.5 kg/m2 or >35.0 kg/m2, History of seizures or use of anticonvulsant medication, History of serotonin syndrome events, Change of antidepressants including bupropion due to psychiatric condition within 3 months prior to Visit 0, Pre-existing cardiovascular disorders including moderate and severe hypertension (systolic blood pressure =160 mmHg, diastolic blood pressure =100 mmHg), heart failure, myocardial infarction, etc., Significant hepatic, gastrointestinal, renal, haematological or oncologic disorder, Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria, Diagnosis or family history of Tourette's syndrome or dystonia, Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke, Immunodeficiency disorders (e.g., organ transplantation, HIV infection), Known hypersensitivity to any of the ingredients of the trial medication