DEXAMFETAMINE SULFATE for Attention deficit hyperactivity disorder | Major depressive disorder

Inclusion criteria

• {"criterion_text":"-Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 or ICD guidelines) which started in childhood (at the age of <12 years)"}
• {"criterion_text":"-Patient has a minimum ADHS-DC-Q total score of 32 at baseline (V0)"}
• {"criterion_text":"-Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a MADRS score of >20 at baseline (V0)"}
• {"criterion_text":"-CGI-S ≥ 4 at baseline (V0)"}
• {"criterion_text":"-Patients receiving SSRIs or SNRIs (stable doses within the last 2 weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mg venlafaxine extended release)"}
• {"criterion_text":"-Male or female patients ≥ 18 years and ≤ 65 at time of enrolment"}
• {"criterion_text":"-Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)"}
• {"criterion_text":"-Written informed consent and data protection declaration obtained prior to the initiation of any protocol required procedures"}
• {"criterion_text":"-Willing and able to comply to study procedures and study protocol"}

Exclusion criteria

• {"criterion_text":"-Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes"}
• {"criterion_text":"-Diagnosis or family history of Tourette’s syndrome or dystonia"}
• {"criterion_text":"-Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke"}
• {"criterion_text":"-Immunodeficiency disorders (e.g. organ transplantation, HIV infection)"}
• {"criterion_text":"-Known hypersensitivity to any of the ingredients of the trial medication, e.g. patients with known rare hereditary problems of fructose intolerance"}
• {"criterion_text":"-Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, IUD) during the study period (Screening to Follow-up)"}
• {"criterion_text":"-Pregnancy and lactation"}
• {"criterion_text":"-Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start"}
• {"criterion_text":"-Patients who are institutionalised by court order or regulatory action"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial"}
• {"criterion_text":"-Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry"}
• {"criterion_text":"-Current use and use within the last 2 weeks before inclusion of not permitted concomitant medication (as defined in protocol) due to possible interactions with stimulants or SSRIs/SNRIs and possible resulting or expected side effects:"}
• {"criterion_text":"-Patients with body mass index (BMI) < 18.5 kg/m² or >35 kg/m²"}
• {"criterion_text":"-History of serotonin syndrome events"}
• {"criterion_text":"-History of seizures or use of anticonvulsant medication"}
• {"criterion_text":"-Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation"}
• {"criterion_text":"-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)"}
• {"criterion_text":"-Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder"}
• {"criterion_text":"-Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria"}

Primary endpoints

• {"endpoint_text":"-Incidence of adverse events (AE) in the active treatment groups (DEX XL and DEX IR) compared to the placebo until V6","definition_or_measurement_approach":"Incidence of adverse events collected throughout the study visits, compared between DEX XL, DEX IR and placebo within the study period (V1 – V6)"}

Secondary endpoints

• {"endpoint_text":"-Incidence of adverse events (AE) until V5","definition_or_measurement_approach":"Incidence of AEs recorded up to visit V5"}
• {"endpoint_text":"-Proportion of patients with at least one AE until V5 and until end of study","definition_or_measurement_approach":"Proportion of patients experiencing ≥1 AE assessed at V5 and at end of study"}
• {"endpoint_text":"-Number of AE until V5 and until end of study","definition_or_measurement_approach":"Count of AEs recorded up to V5 and to study end"}
• {"endpoint_text":"-Number of AE/SAE during the study period, number and proportion of patients with AE/SAE by type, severity (mild, moderate, severe) and relatedness to treatment","definition_or_measurement_approach":"Categorisation and counts of AE/SAE by type, severity and relatedness during study period"}
• {"endpoint_text":"-Score of CGI Efficacy index by investigator at Visit 5","definition_or_measurement_approach":"Investigator-rated CGI Efficacy index measured at Visit 5"}
• {"endpoint_text":"-MADRS suicidal ideation score (range 0-6) for all available visits (SCR to V5) and change to BL/V0 (only V1 to V5)","definition_or_measurement_approach":"MADRS suicidal ideation item score collected from screening to V5 and change from baseline (V0) for V1–V5"}
• {"endpoint_text":"-Rate of patients with score 1-3 in CGI-I at V5","definition_or_measurement_approach":"Proportion of patients with CGI-I score 1–3 at Visit 5"}
• {"endpoint_text":"-Absolute scores categories of CGI-I at all available visits (V1 to V5)","definition_or_measurement_approach":"Categorical CGI-I scores recorded at visits V1–V5"}
• {"endpoint_text":"-Numbers and percentages of patients with (1) decreased, (2) maintained and (3) increased CGI-S at V5 compared to BL/V0","definition_or_measurement_approach":"Shift analysis of CGI-S at V5 vs baseline (V0): counts and percentages in decreased/maintained/increased categories"}
• {"endpoint_text":"-Shift table of CGI-S score categories at BL/V0, V1 and V5","definition_or_measurement_approach":"Shift table comparing CGI-S categories at baseline, V1 and V5"}
• {"endpoint_text":"-Absolute score categories of CGI-S at all available visits (V0 to V5)","definition_or_measurement_approach":"Absolute CGI-S category scores measured at V0–V5"}
• {"endpoint_text":"-MADRS total score (range 0-60) for all available visits (SCR to V5) and change to BL/V0 (only V1 to V5)","definition_or_measurement_approach":"MADRS total scores collected from screening to V5 and change from baseline (V0) for V1–V5"}
• {"endpoint_text":"-MADRS total score categorization by Müller et al. (39) at BL/ V0, V1 and V5 (0-6 absence of symptoms; 7-19 mild depression, 20-34 moderate depression, 35-60 indicate a severe depression)","definition_or_measurement_approach":"MADRS categorisation per Müller et al. at baseline, V1 and V5"}
• {"endpoint_text":"-ADHS-DC-Q total score (range 0-66) for all available visits (SCR to V5) and change to BL/V0 (only V1 to V5)","definition_or_measurement_approach":"ADHS-DC-Q total score measured across visits and change from baseline"}
• {"endpoint_text":"-QIDS-SR-16 total score (range 0-27) for all available visits (V0 to V5) and change to BL/V0 (only V1 to V5)","definition_or_measurement_approach":"QIDS-SR-16 scores collected at V0–V5 and change from baseline"}
• {"endpoint_text":"-Mean dose intake from V1 to V5 per treatment group","definition_or_measurement_approach":"Average actual dose taken between V1 and V5 by treatment group"}
• {"endpoint_text":"-Mean dose intake compared to planned dose after titration phase (for study period V1 to V5) per treatment group","definition_or_measurement_approach":"Comparison of mean actual vs planned dose post-titration for V1–V5"}
• {"endpoint_text":"-Proportion of patients with less than 80% of planned dose intake (for study period V1 to V5) per treatment group","definition_or_measurement_approach":"Percentage of patients taking <80% of planned dose during V1–V5"}
• {"endpoint_text":"-Number and proportion of patients by dosage group (DEX IR: 10 mg, 15 mg, 20 mg, 30 mg; DEX XL: 10 mg, 15 mg, 20 mg, 30 mg; Placebo: 10 mg, 15 mg, 20 mg, 30 mg)) at V1 and V2","definition_or_measurement_approach":"Counts and proportions per predefined dosage groups at V1 and V2"}
• {"endpoint_text":"-Number and proportion of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)","definition_or_measurement_approach":"Counts and proportions of patients requiring dose optimization and type during stable dose phase"}
• {"endpoint_text":"-Number and percentage of patients with early withdrawal from therapy due to adverse events - in total and per treatment group","definition_or_measurement_approach":"Counts and percentages of early withdrawals for AE overall and by treatment group"}

Methods

• Landing page (K1_2024-515395-12-00_Landingpage_ITMP) — online information/entry point indicated by document title
• Werbeanzeige (advertisement) — recruitment advertisement (document titled 'Werbeanzeige')
• Contact form (K1_2024-515395-12-00_Kontaktformular) — web contact form for interested participants
• Privacy information on homepage (K1_2024-515395-12-00_Datenschutzrechtliche_Information_Homepage) — data protection / privacy information for online recruitment

Germany

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

377

Number Of Sites

5

Number Of Participants

105

Primary sponsor

Full Name

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"SocraMetrics GmbH","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Pharmaceutical company"}