Trials / Recruiting
RecruitingNCT06967857
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Prof. Dr. Frank Behrens · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DEX IR tablets | tablet twice daily |
| DRUG | DEX XL | capsule once daily |
| DRUG | Placebo | Placebo to either capsule or tablet |
Timeline
- Start date
- 2025-05-15
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-05-13
- Last updated
- 2026-01-13
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06967857. Inclusion in this directory is not an endorsement.