Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression

Study acronym: DEXAD
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Dec 2026 → Mar 2028
See other at-risk trials from Prof. Dr. Frank Behrens

Record History

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  1. Notable Primary completion pushed from Dec 2026 to Mar 2028 Show 4 more changesShow less
    • Trial sites expanded: 2 → 5 locations
    • Study completion pushed from Dec 2026 to Dec 2028
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 45 of 61 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
3,069 trials monitored
See 170 trials at risk
411 trials monitored
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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.
Trial Details
NCT Number NCT06967857
Lead Sponsor Prof. Dr. Frank Behrens
Conditions
(from sponsor)
Attention-Deficit/Hyperactivity Disorder (ADHD), Depression - Major Depressive Disorder
Related terms Attention Deficit Disorder with Hyperactivity, Depression
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov