Ongoing Clinical Trials for Attention Deficit Hyperactivity Disorder
There are currently 6 clinical trials investigating new treatments for Attention Deficit Hyperactivity Disorder across Europe. These studies are exploring various medications including dexamfetamine sulfate, methylphenidate, lisdexamfetamine, guanfacine, and atomoxetine, with trials taking place in Germany, France, Poland, Belgium, Spain, Sweden, and the Netherlands. The research focuses on improving treatment options for both children and adults with ADHD, including those with co-occurring conditions such as depression, mood disorders, obesity, and type 1 diabetes.
Clinical trial locations
- Belgium
- France
- Germany
- Study on the Safety and Effectiveness of Dexamfetamine Sulfate for Adults with ADHD and Moderate to Severe Depression
- Study on the Effectiveness and Safety of Dexamfetamine Sulfate for Adults with ADHD
- Study on the Safety and Effectiveness of Guanfacine Hydrochloride and Atomoxetine Hydrochloride for Children and Adolescents with ADHD Aged 6 to 17 Years
- Netherlands
- Poland
- Spain
- Sweden
Study on the Safety and Effectiveness of Dexamfetamine Sulfate for Adults with ADHD and Moderate to Severe Depression
This trial investigates two formulations of dexamfetamine sulfate in adults who experience both ADHD and moderate to severe depression. The study focuses on understanding whether this medication can safely and effectively address symptoms of both conditions simultaneously.
Main inclusion criteria: Participants must be adults aged 18 to 65 with a childhood-onset diagnosis of ADHD confirmed before age 12. They must have moderate to severe depression as measured by specific rating scales and a minimum score of 32 on the ADHD symptom test. Participants may be taking certain antidepressants if doses have been stable for at least two weeks. They must be willing to stop current ADHD stimulant medications during the study and have normal heart rhythm measurements.
Main exclusion criteria: The trial excludes individuals who do not have both ADHD and moderate to severe depression, those outside the specified age range, and people not part of the designated clinical trial groups.
Focus and goal: The study aims to evaluate the safety and effectiveness of dexamfetamine sulfate in managing symptoms of both ADHD and depression. Participants will be monitored over a 12-week period through regular check-ups to assess symptom changes, side effects, and overall well-being. The trial compares two forms of the medication—immediate-release and extended-release—against a placebo.
Investigational drugs: The medications being tested are Dexamfetamine Sulfate Immediate Release and Dexamfetamine Sulfate Extended Release. These work by increasing certain brain chemicals that help improve attention, focus, and potentially alleviate depression symptoms. The extended-release version provides longer-lasting effects throughout the day.
Study on How Methylphenidate Works in Adults with ADHD, Comparing Those with and Without Obesity
This French study examines how the body processes the medication Ritalin in adults with ADHD, with particular interest in comparing those living with obesity to those without. The research seeks to understand whether obesity affects how the medication works in the body.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed ADHD diagnosis. They must have been taking Ritalin LP at a stable dose for at least two weeks before joining. For the obesity group, participants need a Body Mass Index of 30 or higher, while the non-obesity group requires a BMI below 30. All participants must be affiliated with social security and provide written consent.
Main exclusion criteria: Individuals without an ADHD diagnosis, those outside the specified age range, and members of vulnerable populations cannot participate.
Focus and goal: The study measures medication levels in the bloodstream at various times after taking Ritalin through blood sample collection. Researchers will assess how effective participants feel the medication is in managing their symptoms using a simple rating scale. The study also collects information about age, weight, lifestyle habits, and various health markers to better understand the results.
Investigational drug: Methylphenidate works by changing the amounts of certain natural substances in the brain, helping improve attention, focus, and self-control in people with ADHD.
Study on the Effectiveness and Safety of Dexamfetamine Sulfate for Adults with ADHD
This German trial compares two different formulations of dexamfetamine sulfate—immediate-release tablets and modified-release capsules—with a placebo to determine how well these medications manage ADHD symptoms in adults.
Main inclusion criteria: Participants must be at least 18 years old with an ADHD diagnosis confirmed through detailed psychiatric evaluation. The condition must have started in childhood before age 12, with evidence from a specific questionnaire about past symptoms. Participants need minimum scores on ADHD symptom tests and must sign consent forms allowing participation and data use.
Main exclusion criteria: People without an ADHD diagnosis according to specific guidelines, non-adults, and members of vulnerable populations are excluded.
Focus and goal: The 44-week study randomly assigns participants to receive either immediate-release tablets, modified-release capsules, or placebo. Neither participants nor researchers know which treatment is given, ensuring unbiased results. Regular monitoring visits assess symptom changes and side effects to determine the optimal dose and evaluate long-term effectiveness and safety.
Investigational drugs: Dexamfetamine Sulfate Immediate-Release provides rapid onset of effects by affecting brain chemicals that contribute to hyperactivity and impulse control. The Modified-Release version releases medication slowly over time, maintaining effects throughout the day for longer-lasting symptom control.
Study on the Effects of Methylphenidate on Brain Function in Adults with ADHD, with or without Mood Disorders, Compared to Placebo
This French research uses advanced brain imaging techniques to understand how methylphenidate affects brain activity in adults with ADHD, both with and without mood disorders such as depression or bipolar disorder.
Main inclusion criteria: Participants must be between 18 and 60 years old with social health insurance. They must understand the study goals, provide signed consent, and agree not to use illegal drugs during the study. Women of childbearing age need negative pregnancy tests and must use effective birth control. The ADHD group must have symptoms present before age 12. Those with mood disorders must be in stable condition for at least six weeks. A healthy control group without psychiatric or neurological history is also included.
Main exclusion criteria: The trial excludes people with significant mental health disorders beyond ADHD or attention deficit related to mood disorders, those with severe heart problems or recent stroke, individuals using illegal drugs or abusing alcohol, pregnant or breastfeeding women, recent participants in other trials, and those allergic to methylphenidate.
Focus and goal: The study uses EEG and MRI imaging to observe brain activity changes during tasks and rest periods. Researchers measure brain blood flow and cognitive performance to understand how methylphenidate alters brain function, which could lead to improved treatment strategies.
Investigational drug: Methylphenidate affects certain brain chemicals that contribute to hyperactivity and impulse control, helping improve attention and behavior regulation in adults with ADHD.
Study on Lisdexamfetamine and Methylphenidate for Children with ADHD and Type 1 Diabetes
This Polish study examines two ADHD medications in children and teenagers who also have type 1 diabetes, aiming to determine which medication better manages ADHD symptoms while considering effects on diabetes control.
Main inclusion criteria: Participants must be between 8 and 16.5 years old with type 1 diabetes diagnosed based on specific autoantibodies or low C-peptide levels. They must have had diabetes for at least 12 months, managed with functional intensive insulin therapy. An ADHD diagnosis confirmed by a psychiatrist is required. Participants need Polish citizenship and health insurance. Those who can become pregnant must use effective birth control throughout the study.
Main exclusion criteria: Children without type 1 diabetes or ADHD cannot participate, nor can those outside the specified age range or members of vulnerable populations.
Focus and goal: The six-month crossover study allows participants to try both medications at different times for comparison. Researchers monitor ADHD symptoms and diabetes management, including blood sugar levels and side effects, to help doctors make better treatment decisions for children with both conditions.
Investigational drugs: Lisdexamfetamine affects brain chemicals contributing to hyperactivity and impulse control. Methylphenidate helps increase attention and decrease impulsiveness and hyperactivity. The trial compares their effectiveness and safety in children who also have type 1 diabetes.
Study on the Safety and Effectiveness of Guanfacine Hydrochloride and Atomoxetine Hydrochloride for Children and Adolescents with ADHD Aged 6 to 17 Years
This multinational trial studies guanfacine hydrochloride in children and adolescents aged 6 to 17 who cannot use stimulant medications for ADHD due to intolerance or ineffectiveness. The study compares it with atomoxetine hydrochloride and placebo.
Main inclusion criteria: Participants must be aged 6 to 17 with age-appropriate intellectual functioning and ability to swallow tablets. Girls aged 9 or older must have negative pregnancy tests and agree to use birth control if required. Blood pressure must be within normal ranges. Participants need an ADHD diagnosis and must have tried stimulant medications that proved unsuitable. They must meet minimum scores on ADHD symptom scales. Parents or guardians must provide consent, and participants must agree to follow all study requirements.
Main exclusion criteria: The trial excludes those with medical conditions that might interfere with the study, those taking medications affecting study results, individuals with severe allergies, history of substance abuse, serious mental health conditions, pregnancy or breastfeeding, recent participation in other trials, family history of certain heart conditions, history of seizures, or significant medical conditions making participation unsafe.
Focus and goal: The 12-month trial includes dose optimization followed by regular medication intake. Researchers use computer-based tests to monitor attention and reaction times, evaluating long-term safety and effects on cognitive functions. The study also tracks weight, height, blood pressure, and heart rate.
Investigational drugs: Guanfacine Hydrochloride Prolonged-release affects parts of the brain to improve attention, focus, and impulse control, releasing slowly for steady effects throughout the day. Atomoxetine increases brain chemical levels that help with attention and impulse control. Unlike stimulants, it works differently and may suit those who cannot tolerate stimulant medications.
Summary
The six ongoing clinical trials for ADHD demonstrate a diverse research landscape addressing various patient populations and co-occurring conditions. Notably, Germany hosts two trials focused on dexamfetamine sulfate formulations, while France conducts two studies examining methylphenidate’s effects on brain function and metabolism. The research spans multiple countries including Belgium, Spain, Sweden, and the Netherlands, indicating strong European collaboration.
A significant portion of the research targets adults with ADHD, including those with co-occurring conditions such as depression, mood disorders, and obesity. This reflects growing recognition that ADHD extends into adulthood and often presents alongside other health challenges. Three trials specifically focus on pediatric populations, including children with type 1 diabetes and those unable to tolerate stimulant medications, addressing important gaps in treatment options for vulnerable groups.
The investigational drugs include various stimulant medications such as dexamfetamine sulfate, methylphenidate, and lisdexamfetamine, as well as non-stimulant options like guanfacine and atomoxetine. This variety offers hope for patients who may not respond to or tolerate traditional stimulant therapies. Several studies employ advanced research methods including brain imaging and pharmacokinetic analysis, contributing to deeper understanding of how these medications work at the neurological level.
