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Randomized, placebo-controlled clinical trial to investigate the safety and efficacy of two dexamfetamine sulfate formulations in adults with ADHD and moderate to severe depression (DEXAD)
EU CTIS ID: 2024-515395-12-00
What this study is testing
to assess the incidence of adverse events in the active treatment groups (DEX IR and DEX XL) compared to placebo within the study period (V1 – V6)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 or ICD guidelines) which started in childhood (at the age of <12 years)
- Patient is either free of stimulant medication or who, after discussion with his / her treating physician, is able and willing to discontinue the current psychotropic medication(s) for treatment of ADHD symptoms (specifically, methylphenidate, lisdexamfetamine, guanfacine or atomoxetine or any other medication approved for the treatment of ADHD) ) for the duration of the study, as well as is able and willing to discontinue all relevant co-medication according to exclusion criterion no. 20a-s for comorbid conditions during the clinical trial, if applicable
- Patient has a minimum ADHS-DC-Q total score of 32 at baseline (V0)
- 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)
- CGI-S ≥ 4 at baseline (V0)
- 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)
You likely can't join if
- Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes
- 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, e.g. patients with known rare hereditary problems of fructose intolerance
- 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)
See the full eligibility criteria
Who can join
- Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 or ICD guidelines) which started in childhood (at the age of <12 years)
- Patient is either free of stimulant medication or who, after discussion with his / her treating physician, is able and willing to discontinue the current psychotropic medication(s) for treatment of ADHD symptoms (specifically, methylphenidate, lisdexamfetamine, guanfacine or atomoxetine or any other medication approved for the treatment of ADHD) ) for the duration of the study, as well as is able and willing to discontinue all relevant co-medication according to exclusion criterion no. 20a-s for comorbid conditions during the clinical trial, if applicable
- Patient has a minimum ADHS-DC-Q total score of 32 at baseline (V0)
- 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)
- CGI-S ≥ 4 at baseline (V0)
- 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)
- Male or female patients ≥ 18 years and ≤ 65 at time of enrolment
- Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)
- Written informed consent and data protection declaration obtained prior to the initiation of any protocol required procedures
- Willing and able to comply to study procedures and study protocol
What rules you out
- Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes
- 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, e.g. patients with known rare hereditary problems of fructose intolerance
- 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)
- Pregnancy and lactation
- 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
- Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry
- 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:
- Patients with body mass index (BMI) < 18.5 kg/m² or >35 kg/m²
- History of serotonin syndrome events
- History of seizures or use of anticonvulsant medication
- Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation
- 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)
- Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder
- Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.