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Testing dehydroepiandrosterone combined with standard antidepressants for patients with treatment-resistant depression

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What is this study about?

This study is looking at Treatment Resistant Depression, which is a type of depression that does not improve enough even after trying at least one standard treatment with antidepressant medication. The study will test whether adding Dehydroepiandrosterone, also known as DHEA, to the regular antidepressant medication that patients are already taking can help improve depression symptoms better than adding a placebo. DHEA is a substance that occurs naturally in the body and will be given as a tablet in addition to the current depression treatment.

The purpose of this study is to find out if taking 100 milligrams of DHEA daily along with continued standard antidepressant medication works better at reducing depression symptoms than taking placebo along with the same antidepressant medication. Participants will continue taking their regular antidepressant medicine, which could be medications such as SSRI, SNRI, tricyclic antidepressants, mirtazapine, or bupropion, and will additionally receive either DHEA or placebo tablets to take by mouth.

The study treatment will last for six months. During this time, depression symptoms will be measured using rating scales that help doctors understand how severe the depression is and whether it is getting better. The study will also look at whether participants respond to treatment, which means their depression symptoms are reduced by half, and whether they achieve remission, which means their depression symptoms become very mild. Other measurements will include quality of life, overall functioning, and various blood tests to check things like blood sugar and cholesterol levels. The study will also monitor any side effects and how well participants tolerate the treatment.

1 Baseline assessment and treatment start

At the beginning of the study, your current level of depression will be measured using a scale called the Montgomery-Asberg Depression Rating Scale. This is a questionnaire that assesses the severity of depression symptoms.

You will continue taking your current antidepressant medication, which may be one of the following types: SSRI, SNRI, tricyclic antidepressant, mirtazapine, or bupropion. The dose and type of this medication will remain unchanged throughout the study.

In addition to your regular antidepressant, you will start taking the study medication. This will be either prasterone (also known as DHEA) at a dose of 100 mg per day, or a placebo (an inactive tablet that looks identical to the active medication). The study medication is taken orally as a tablet.

You will not know whether you are receiving the active medication or placebo, as this is determined randomly and kept confidential to ensure unbiased results.

2 Treatment period

You will take the study medication daily for a period of 6 weeks.

During this time, you will continue taking your regular antidepressant medication at the same dose as before.

The study medication should be taken orally once per day.

3 Assessment at week 6

At the end of the 6-week treatment period, your depression symptoms will be assessed again using the Montgomery-Asberg Depression Rating Scale.

Additional questionnaires will be completed to evaluate your depression severity, overall improvement, quality of life, and daily functioning. These include measures of your own impression of change and your ability to perform social and occupational activities.

Blood samples will be taken to measure various health markers, including glucose (blood sugar), HbA1c (average blood sugar over the past 2-3 months), cholesterol levels (total, HDL, and LDL), and markers of inflammation in the body.

Any side effects or unwanted reactions that occurred during the treatment period will be recorded and assessed.

Who Can Join the Study?

  • You must provide written informed consent, which means you agree in writing to take part in the study after understanding what it involves
  • You must be able to give consent, meaning you can clearly understand what the study is about, what it means for you, and what the possible risks are
  • You must be between 18 and 75 years old
  • You must have an episode of major depression, which is a type of serious depression that affects your mood, thoughts, and daily activities
  • You must have treatment-resistant depression, which means your depression has not improved after trying at least one antidepressant medicine for at least 4 weeks, including your current treatment
  • You must have a score of at least 20 on the Montgomery-Asberg Depression Rating Scale, which is a questionnaire that measures how severe your depression symptoms are
  • You must be taking an antidepressant medicine for at least 4 weeks, the dose must be at the minimum treatment level or higher, and the dose must not have changed for at least 14 days before the screening visit
  • You must have tried fewer than three different antidepressant medicines during your current depression episode, not counting the medicine you are taking now

Who Cannot Join the Study?

  • You cannot participate if you have bipolar disorder, which is a condition where mood swings between very high energy and depression
  • You cannot participate if you have psychotic symptoms, which means experiencing things like hearing voices or seeing things that are not real
  • You cannot participate if you have schizophrenia, which is a serious mental health condition affecting how a person thinks, feels, and behaves
  • You cannot participate if you are pregnant or planning to become pregnant during the study
  • You cannot participate if you are breastfeeding
  • You cannot participate if you have a history of hormone-sensitive cancers, which are cancers that grow in response to certain hormones in the body, such as breast or prostate cancer
  • You cannot participate if you have serious liver disease, which means your liver is not working properly
  • You cannot participate if you have serious kidney disease, which means your kidneys are not filtering waste from your blood properly
  • You cannot participate if you have active substance abuse, which means currently using drugs or alcohol in a harmful way
  • You cannot participate if you have a serious unstable medical condition that requires immediate treatment
  • You cannot participate if you are allergic to DHEA, which is the study medication being tested
  • You cannot participate if you are currently taking hormone replacement therapy or steroid medications
  • You cannot participate if you have had thoughts of harming yourself that require immediate medical attention

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 Status
HELIOS Hanseklinikum Stralsund GmbH Stralsund Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Ludwig Maximilian University Of Munich Munich Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Ushlrhseug Mvxtyzq Cgmuhj Hywyeczszfyreylvn Hamburg Germany
Bjrjegsgyefonpy Srwflblk Kt Ativqwc dqk ovadlzzirmas Rqhobh dzb Bitwjiw Sjfeqgak Augsburg Germany
Gjftac Uazfsaiali Fmdawjwph Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
30.09.2025

Trial locations

Investigated drugs:

Dehydroepiandrosterone (DHEA) is a hormone that is naturally produced by your body. In this trial, it is being tested as an additional treatment to be taken along with your regular antidepressant medication. The researchers want to see if adding DHEA to your current antidepressant can help improve depression symptoms better than taking the antidepressant alone. DHEA is being studied to find out if it can help people whose depression has not improved enough with standard antidepressant treatments.

Investigated diseases:

Treatment Resistant Depression – Treatment resistant depression is a form of major depressive disorder that does not respond adequately to standard antidepressant treatments. People with this condition continue to experience persistent feelings of sadness, loss of interest in activities, and other depressive symptoms despite trying multiple antidepressant medications. The condition significantly affects daily functioning, relationships, and quality of life. Symptoms may include changes in sleep patterns, appetite, energy levels, and concentration. The depression persists even after at least two different antidepressant treatments have been tried at adequate doses and duration. This ongoing nature of symptoms can lead to increased disability and reduced ability to perform everyday tasks.

Trial ID:
2024-517963-21-00
Protocol code:
DARE-Trial
Trial Phase:
Therapeutic confirmatory (Phase III)

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