RecruitingPhase 2NCT06967857

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)


Sponsor

Prof. Dr. Frank Behrens

Enrollment

105 participants

Start Date

May 15, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two different forms of a medication called dexamfetamine sulfate in adults who have both ADHD and moderate-to-severe depression, to see if treating both conditions together leads to better outcomes. **You may be eligible if...** - You are an adult with a diagnosed ADHD condition that started in childhood - You also have moderate to severe depression - Your ADHD symptoms began before age 12 - You are willing to participate in the full study period **You may NOT be eligible if...** - You have a history of heart problems or high blood pressure that is not controlled - You have a history of psychosis, bipolar disorder, or substance abuse - You are currently taking medications that interact with stimulants (such as certain antidepressants called MAOIs) - You are pregnant or breastfeeding - You have severe anxiety or significant thyroid problems Talk to your doctor to see if this trial is right for you.

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

DRUGDEX IR tablets

tablet twice daily

DRUGDEX XL

capsule once daily

DRUGPlacebo

Placebo to either capsule or tablet


Locations(2)

Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University

Frankfurt, Germany

University Leipzig, Department of Psychiatry and Psychotherapy

Leipzig, Germany

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NCT06967857


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