The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD. The prevalence of comorbid depression in adults with ADHD is estimated to be as high as 50%.
There is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive processes in the prefrontal cortex (PFC). In combination with the pharmacological effects of stimulants, such as the inhibition of monoamine oxidase, the increase in the concentration of noradrenaline in the PFC and dopamine in the striatum, dexamfetamine and methylphenidate could improve the treatment of depression in patients with major depressive disorder and comorbid ADHD.
This clinical trial will evaluate the safety and efficacy of DEX in two different formulations compared to placebo in adults with ADHD and moderate to severe depression. To ensure double blinding of the treatment, placebo will be administered in the form of tablets and capsules.
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)
Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0)
Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of >20 at baseline (V0)
CGI-S ≥ 4 at baseline (V0)
Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes
Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry
Patients with body mass index (BMI) < 18.5 kg/m² or >35 kg/m²
History of serotonin syndrome events
Parallel
DEX IR tablets
Drugtablet twice daily
DEX XL
Drugcapsule once daily
Placebo
DrugPlacebo to either capsule or tablet
Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6
Incidence of adverse events (AE) in the active treatment groups (DEX XL and DEX IR) compared to the placebo until V6
Incidence of adverse events (AE) until V5
Dokumentation of AE
Proportion of patients with at least one AE until V5
Proportion of patients with at least one AE until V5
Proportion of patients with at least one AE until end of study
Proportion of patients with at least one AE until end of study
Number of AE until V5
Number of AE
Click on the lead sponsor to view all of their trials.
Prof. Dr. Frank Behrens
Lead sponsor
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Sponsor institution
