Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression
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)
Prof. Dr. Frank Behrens
105 participants
May 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
tablet twice daily
capsule once daily
Placebo to either capsule or tablet
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06967857