AuthorisedTherapeutic confirmatory (Phase III)Interventional

Dehydroepiandrosterone (DHEA) as augmentation of standard antidepressants in treatment-resistant depression: a randomized controlled trial (DARE-Trial) - A multicenter, randomized, double-blind, placebo-controlled trial with group sequential design

This study is looking into a new approach for people struggling with depression that hasn't responded to standard treatments. It's called the DARE-Trial and involves a tablet called Biosteron (which contains DHEA). Participants will take this new tablet in addition to their regular antidepressant medication, or they will take a dummy pill (placebo) alongside their regular medication, without knowing which they've received. The main goal is to measure changes in depression symptoms after six weeks using a common depression scale. Researchers will also be checking if participants feel better, how safe the treatment is, and if it improves their overall well-being. This is a Phase III trial, meaning it's a key step in checking if the treatment works and is safe before it might become more widely available.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

320

Start

04 Nov 2025

Treatment Resistant Depression (TRD)

What is this study about?

Many people find that their depression doesn't fully improve, even after trying different antidepressant medications. This can be very frustrating and challenging. This study is designed specifically for these individuals, looking at whether adding a particular tablet, called DHEA (Biosteron), to their current antidepressant treatment could be helpful. DHEA is a substance naturally made in the body, and researchers are exploring its potential role in relieving depression.

Participants in this study will be randomly assigned to one of two groups. One group will receive the DHEA tablet, and the other will receive a placebo, which looks identical but contains no active medicine. Neither the participants nor their doctors will know who is getting which tablet – this is called a "double-blind" study and helps ensure the results are as fair and unbiased as possible. Everyone in the study will continue to take their standard antidepressant medication throughout the six-week study period.

The main thing researchers want to find out is how much depression symptoms change in both groups after six weeks. They will use a widely recognised scale to measure symptoms. They'll also be looking at several other important aspects, such as how many people feel significantly better, whether their depression goes into remission (meaning very few symptoms remain), and how their overall quality of life and general well-being are affected. Importantly, the study will also closely monitor for any side effects and how well people tolerate the treatment.

Key takeaways

Tests DHEA tablets for depression that hasn't improved with other treatments.
Compares DHEA plus usual care with a dummy pill plus usual care.
Main goal is to see if depression symptoms improve after six weeks.
Close monitoring for safety, side effects, and overall well-being.
Open to adults aged 18 and over with treatment-resistant depression.
Participation involves taking tablets and attending regular clinic visits.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or over. There is no upper age limit, and the study is open to both men and women.

The most important requirement is that you have been diagnosed with depression that hasn't improved as much as hoped with other treatments. This is often referred to as 'treatment-resistant depression'. Your current treatment must include antidepressant medication.

While the study aims to include a broad range of people, there will be specific medical criteria to ensure it's safe for you to participate. This might include checking certain blood test results or whether you have other medical conditions that would make taking DHEA unsuitable.

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 18 years old or older?
Have you been diagnosed with depression?
Have your depression symptoms not fully improved with your current antidepressant treatment?
Are you currently taking antidepressant medication?
Are you willing to attend regular clinic visits for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given study tablets (either DHEA or a dummy pill) to take alongside your usual antidepressant medication for six weeks. You won't know which tablet you're receiving. You will have regular visits to the study clinic, likely weekly or bi-weekly initially, and then less frequently. During these visits, the study team will carry out assessments to monitor your depression symptoms using questionnaires and scales, check your general health, and record any side effects you might experience. They will also take blood samples at the start and end of the study to check various health markers like blood sugar and cholesterol. Your well-being and how you feel will be important parts of these assessments. The total active study period will last for six weeks, with follow-up assessments afterwards.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment approach that could potentially improve your depression symptoms where other treatments haven't fully worked. You would also receive close medical attention and monitoring throughout the study. However, some people may experience side effects from the DHEA tablet, or it may not improve their symptoms. There's also a chance you could receive the placebo (dummy pill) and not the active treatment. All medical treatments carry some level of risk, and the research team will carefully monitor your health. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is DHEA?

DHEA is a hormone naturally made in your body. This study is testing if adding it to antidepressants can help with depression that hasn't fully responded to other treatments.

Will I know if I'm getting the real drug or a dummy pill?

No, neither you nor your doctor will know if you're receiving the DHEA tablet or a placebo (dummy pill) during the study. This helps make the study results more reliable.

How long does the study treatment last?

You will take the study tablets for six weeks as part of the main treatment period. There will be follow-up assessments after this time.

What kind of visits will I need to make?

You'll have regular visits to the study clinic, likely weekly or every two weeks at first, for check-ups, questionnaires, and possibly blood tests.

Can I stop participating if I don't like it?

Yes, you can leave the study at any time, for any reason, without it affecting the medical care you receive for your depression.