Study on the Safety and Effectiveness of Dexamfetamine Sulfate for Adults with ADHD and Moderate to Severe Depression

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What is this study about?

This clinical trial is focused on studying the effects of two formulations of dexamfetamine sulfate in adults who have both Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe depression. The study aims to understand the safety and effectiveness of these medications. Participants will receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient. The medications being tested are Dexamfetamine sulfate 10 mg, 15 mg, and 20 mg modified-release capsules and Attentin 5 mg and 10 mg tablets.

The purpose of the study is to assess the occurrence of any side effects in those taking the active medications compared to those taking the placebo. The study will take place over several visits, where participants will be monitored for any changes in their condition and any side effects they might experience. The study will last for a maximum of 12 weeks, during which participants will be asked to take the medication or placebo daily.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The goal is to gather information on how well the medications work and how safe they are for people with both ADHD and depression. This information will help in understanding the potential benefits and risks of using dexamfetamine sulfate for treating these conditions together.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of attention deficit/hyperactivity disorder (ADHD) and moderate to severe depression.

Eligibility is based on specific criteria, such as age, current medication status, and health conditions.

2 baseline visit

A baseline visit (V0) is conducted to record initial health status and scores on various scales, such as the ADHS-DC-Q and MADRS.

This visit establishes a starting point for measuring changes throughout the trial.

3 randomization and treatment allocation

Participants are randomly assigned to one of the treatment groups: DEX IR (immediate-release), DEX XL (extended-release), or placebo.

The specific medication and dosage are determined based on the group assignment.

4 treatment phase

Participants begin taking the assigned medication orally. Options include dexamfetamine sulfate in modified-release capsules (10 mg, 15 mg, or 20 mg) or Attentin tablets (5 mg or 10 mg).

The treatment phase involves regular intake of the medication as prescribed, with adjustments made as necessary to optimize dosage.

5 regular monitoring visits

Regular visits (V1 to V6) are scheduled to monitor health status, medication effects, and any adverse events.

These visits include assessments of symptoms, side effects, and overall well-being.

6 final assessment

A final assessment is conducted at the end of the study period to evaluate the overall impact of the treatment.

This includes measuring changes in ADHD and depression symptoms, as well as recording any adverse events experienced during the trial.

Who Can Join the Study?

Must have a diagnosis of attention deficit/hyperactivity disorder (ADHD) that started in childhood, before the age of 12. ADHD is a condition that affects attention and behavior.
Must be free of stimulant medication or willing to stop current ADHD medications, such as methylphenidate, lisdexamfetamine, guanfacine, or atomoxetine, during the study. Also, must be willing to stop other related medications if needed.
Must have a minimum score of 32 on the ADHS-DC-Q test at the start of the study. This test measures ADHD symptoms.
Must have moderate to severe depression according to ICD-10 guidelines, with a MADRS score of more than 20 at the start. The MADRS score is a way to measure depression severity.
Must have a CGI-S score of 4 or higher at the start. CGI-S is a scale that measures the severity of mental illness.
Can be taking SSRIs or SNRIs (types of antidepressants) if the doses have been stable for at least two weeks before joining. Examples include up to 40 mg of (es)citalopram, 50-200 mg of sertraline, or 75-300 mg of venlafaxine extended release.
Must be between 18 and 65 years old at the time of joining the study.
Must have a QTc interval within normal ranges on an ECG test. This is a measure of heart rhythm, with normal being 470 ms or less for males and 480 ms or less for females.
Must provide written informed consent and agree to data protection terms before starting any study procedures.
Must be willing and able to follow the study procedures and protocol.

Who Cannot Join the Study?

Patients who do not have both ADHD (Attention Deficit Hyperactivity Disorder) and moderate to severe depression cannot participate.
Individuals who are not adults are excluded from the study.
Participants who are not within the specified age range for the study are not eligible.
People who are not part of the specified clinical trial groups cannot join the study.
Individuals who are not considered part of a vulnerable population are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Gyzcan Uocywcultu Fsjsvrjqs	Frankfurt	Germany
Kgfjmjmc ddj Ufnxzzudulzh Mhfdrbww Akh	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.03.2025

Trial locations

Investigated drugs:

Dexamfetamine Sulfate

Dexamfetamine Sulfate Immediate Release (DEX IR) is a medication used in this trial to help manage symptoms of ADHD and depression. It works by increasing the levels of certain chemicals in the brain that help improve attention and focus, while also potentially alleviating symptoms of depression.

Dexamfetamine Sulfate Extended Release (DEX XL) is another formulation of the same medication, designed to release the active ingredient slowly over time. This helps maintain a more consistent level of the medication in the body, which can provide longer-lasting effects in managing ADHD and depression symptoms throughout the day.

Investigated diseases:

Attention-Deficit/Hyperactivity Disorder (ADHD) – A neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. Symptoms often include difficulty sustaining attention, forgetfulness, fidgeting, and excessive talking. These behaviors are more severe, frequent, and disruptive than typically observed in individuals at a comparable level of development. ADHD can affect academic, occupational, and social functioning. The disorder is usually diagnosed in childhood but can continue into adulthood. The exact cause is not known, but genetics, brain structure, and environmental factors may play a role.

Major Depressive Disorder (Moderate to Severe) – A mental health condition marked by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can significantly impair daily functioning and quality of life. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The severity of depression is categorized based on the number and intensity of symptoms. Moderate to severe depression involves more pronounced symptoms that interfere with social, occupational, or other important areas of functioning. The exact cause is complex and may involve genetic, biological, environmental, and psychological factors.

Trial ID:

2024-515395-12-00

Protocol code:

TMP-18122023-58

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Dexamfetamine Sulfate for Adults with ADHD and Moderate to Severe Depression

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?