RecruitingPHASE2INTERVENTIONAL

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

This study is for adults aged 18 to 65 who have been diagnosed with both ADHD and moderate to severe depression. Many people with ADHD also experience depression, and current treatments might not always cover both conditions well. We are testing two different forms of a medication called dexamfetamine (DEX IR tablets and DEX XL) against a placebo (a dummy pill). The main goal is to find out if these dexamfetamine medications are safe and effective in helping to improve symptoms of both ADHD and depression. Participants will receive either one of the active medications or a placebo, and neither they nor their doctors will know which one they are taking until the study ends. This helps us get the most accurate results.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Prof. Dr. Frank Behrens

Enrolment target

105

Start

15 May 2025

Estimated completion

01 Dec 2026

Attention-Deficit/Hyperactivity Disorder (ADHD)Depression - Major Depressive Disorder

What is this study about?

This study is looking into new ways to help adults who have both Attention-Deficit/Hyperactivity Disorder (ADHD) and depression. It's quite common for adults with ADHD to also experience depression, sometimes affecting up to half of them. This can make treatment more complicated, as medications that help one condition might not fully address the other.

We know that stimulant medications, like dexamfetamine, can improve things like focus, memory, and thinking skills in people with ADHD. There's also reason to believe these types of medications might help improve symptoms of depression, especially in people who have both conditions. This study will specifically compare two different versions of a dexamfetamine medication (DEX IR tablets and DEX XL) with a placebo, which is a dummy pill that contains no active medicine.

The main aim of this research is to see if these dexamfetamine medications are safe and truly effective for adults dealing with both ADHD and moderate to severe depression. Everyone involved in the study, including the patients and their doctors, will not know who is receiving the active medication and who is receiving the placebo. This 'blinded' approach helps ensure the results are as fair and unbiased as possible when judging how well the treatments work.

Key takeaways

This study is for adults (18-65) with ADHD and moderate to severe depression.
It tests two forms of dexamfetamine against a placebo (dummy pill).
The goal is to see if the medications are safe and effective for both conditions.
Participants, and their doctors, won't know if they're getting active drug or placebo.
Regular clinic visits, medical checks, and questionnaires will be part of the study.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old. You must have received a formal diagnosis of ADHD that started when you were a child, and your ADHD symptoms need to meet a certain level of severity. You also need to have been diagnosed with moderate to severe depression and have depression symptoms that meet a specific score on a rating scale.

You should also be taking certain types of antidepressant medications (like some SSRIs or SNRIs) at a stable dose for at least two weeks before the study starts. You'd also need to be willing to stop any current ADHD stimulant medications, or any other ADHD medicines you're taking, for the duration of the study. Your heart health, specifically an electrical measurement of your heart called a QTc interval, must be within normal limits.

There are also reasons you might not be able to join. For example, if you have or have had severe mental health problems like psychosis, or certain other medical conditions, you might not be eligible. The study team will go through a full list with you to check if this study is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have a lifelong diagnosis of ADHD that started in childhood?
Do you also have a diagnosis of moderate to severe depression?
Are you currently taking certain types of antidepressant medications at a stable dose?
Are you able and willing to stop your current ADHD medications for the study duration?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. This involves medical checks and questionnaires. If you qualify, you'll be randomly assigned to receive one of the two active dexamfetamine medications (either DEX IR tablets or DEX XL) or a placebo (dummy pill). You won't know which one you're taking, nor will your study doctor. Medication will be provided in either tablet or capsule form.

Throughout the study, you'll have regular visits to the clinic for assessments. These will include medical examinations, blood tests, and completing questionnaires about your ADHD and depression symptoms. These visits help the study team monitor your progress and ensure your safety. There will also be follow-up calls or visits after your treatment period ends to check on your well-being. The total length of your involvement in the study will be explained in detail by the study team during the screening process.

Potential risks and benefits

Taking part in this study could potentially help us understand how to better treat adults with both ADHD and depression, which could benefit you directly or others in the future. However, there's no guarantee that you will receive the active medication or that it will help your symptoms. All medications have potential side effects, and dexamfetamine is no exception. The study team will carefully monitor you for any side effects, and you'll be given a full list of potential risks before you decide to join. Remember, taking part is completely voluntary, and you can change your mind and withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University
Verified postcode
Frankfurt, Germany· Recruiting
University Leipzig, Department of Psychiatry and Psychotherapy
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is dexamfetamine?

Dexamfetamine is a type of stimulant medication often used to help with ADHD symptoms like focus and attention.

What is a placebo?

A placebo is a 'dummy' pill that looks like the study medication but contains no active ingredients. It helps us compare the real medication's effects.

What does 'double-blind' mean?

Double-blind means neither you nor your study doctor will know if you're receiving the active medication or the placebo until the study is over. This prevents bias.

What is ADHD and depression co-occurring?

It means someone has both Attention-Deficit/Hyperactivity Disorder and depression at the same time, which is quite common in adults.

Can I stop my current ADHD medication to join?

You might need to stop certain ADHD medications, but this will be discussed specifically with you and your doctor to ensure it's safe if you decide to participate.

How to find out more

Christin Jonetzko

christin.jonetzko@itmp.fraunhofer.de +49 69 630180210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.