Actively Recruiting
Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression
Led by Prof. Dr. Frank Behrens · Updated on 2026-01-13
105
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ADHD according to DSM-5 or ICD guidelines that began before age 12
- ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of at least 32 at baseline
- Moderate to severe depression with ICD-10 codes F32 or F33 and MADRS score over 20 at baseline
- Clinical Global Impressions-Severity (CGI-S) score of 4 or higher at baseline
- Stable doses of SSRIs or SNRIs within the last 2 weeks before inclusion (specific dose limits apply)
- Male or female aged between 18 and 65 years at enrollment
- QTc interval within normal limits (≤470 ms for males, ≤480 ms for females)
- Either not currently taking stimulant medication or able and willing to stop ADHD medications and relevant co-medications during the study
- Provided written informed consent and data protection agreement
- Willing and able to follow study procedures and protocol
You will not qualify if you...
- History or current severe psychiatric symptoms such as psychosis, schizophrenia, bipolar disorder, or manic episodes
- Substance abuse disorder within 6 months prior to trial start
- Body mass index (BMI) below 18.5 kg/m² or above 35 kg/m²
- History of serotonin syndrome
- History of seizures or current use of anticonvulsant medication
- Any uncontrolled psychiatric condition requiring medication or interfering with trial participation
- Known symptomatic cardiovascular disease or significant heart conditions
- Significant liver, gastrointestinal, kidney, blood, or cancer disorders as judged by investigators
- Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma, or porphyria
- Diagnosis or family history of Tourette's syndrome or dystonia
- Pre-existing cerebrovascular disorders like aneurysm, vasculitis, or stroke
- Immunodeficiency disorders including organ transplantation or HIV infection
- Known allergy to trial medication ingredients
- Persons of reproductive potential not willing to use effective contraception during the study
- Pregnancy or breastfeeding
- Participation in another interventional trial within 30 days prior to this study
- Institutionalized by court or regulatory order
- Staff or relatives of the trial center, sponsor, or investigator
- Legal incapacity or inability to understand the trial
- Use within 2 weeks before inclusion of medications that may interact with stimulants or SSRIs/SNRIs, including specified antipsychotics, antidepressants, benzodiazepines, certain antibiotics, opioids, and others
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University
Frankfurt, Germany, 60590
Actively Recruiting
2
University Leipzig, Department of Psychiatry and Psychotherapy
Leipzig, Germany, 04103
Actively Recruiting
Research Team
C
Christin Jonetzko
CONTACT
A
Anja Kuehne
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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