Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 14-week, multicentre, double-blind, randomised, placebo-controlled phase II study with an 8-week treatment period to assess the efficacy and tolerability of a fixed dose of BH-200 (250 mg BID) in outpatients with Major Depressive Disorder (MDD)

This 14-week study is testing a new medicine called BH-200 for people aged 18 and over who have Major Depressive Disorder, also known as severe depression. We want to see if a specific dose of BH-200 can improve symptoms like low mood and lack of interest, and how well people tolerate it compared to a placebo (a dummy pill). Half the participants will receive BH-200 and the other half will receive the placebo, but neither they nor their doctors will know which one they are getting. We'll be checking changes in mood scores, daily activities, and overall well-being. This information will help us understand if BH-200 could be a helpful treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

HMNC Holding GmbH

Enrolment target

274

Start

24 Sep 2024

Major Depressive Disorder

What is this study about?

This study is investigating a new potential treatment for Major Depressive Disorder, often referred to as severe or clinical depression. Many people experience depression, and it can significantly affect their daily lives, including their mood, thoughts, and physical health. While existing treatments are available, researchers are always looking for new and potentially better options with fewer side effects.

Here, we are specifically looking at a medicine called BH-200. This study is in 'Phase II,' which means it's an early stage where we are mainly trying to find out if the medicine works, how well it's tolerated, and to decide on the best dose to study further. We want to see if taking BH-200 can help reduce the symptoms of depression and improve a person's overall quality of life.

To make sure the results are fair and accurate, some participants will receive the active medicine (BH-200), and others will receive a placebo, which looks exactly the same but contains no active ingredient. Neither the participants nor their doctors will know who is getting what until the study is over. This helps prevent any bias when we look at the results. We will regularly check how participants are feeling using questionnaires and assessments, and also monitor any side effects to make sure the medicine is safe.

Key takeaways

This study is testing a new medicine called BH-200 for severe depression.
It aims to see if BH-200 improves mood and daily life, and how safe it is.
Participants will receive either BH-200 or a placebo, but won't know which.
The study involves regular clinic visits for 14 weeks, with 8 weeks of treatment.
Your health will be closely monitored throughout the study.

Who may be eligible?

This study is looking for adults aged 18 and older who have been diagnosed with Major Depressive Disorder. Both men and women can take part. To join, you would need to be able to visit the study clinics regularly.

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 Major Depressive Disorder?
Are you able to attend regular clinic appointments?
Are you willing to take a study capsule twice a day for 8 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for a total of 14 weeks. For 8 of these weeks, you will be taking either the study medicine (BH-200) or a placebo capsule twice a day. You will have regular visits to the clinic, where doctors and nurses will check your health, ask you questions about how you're feeling, and do tests like blood samples and heart checks. You'll complete questionnaires about your mood, anxiety, daily activities, and general well-being. We will also monitor for any side effects you might experience. There will also be a follow-up visit after you stop taking the study medicine to see how you are doing.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving close medical attention and access to a new treatment that isn't widely available yet. However, there's no guarantee that the study medicine will help your depression; you might receive the placebo. All medicines have potential side effects, and you might experience some from BH-200. We will carefully monitor your health throughout the study to ensure your safety. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

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

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Unverified
Spain
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Unverified
Estonia
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Unverified
Slovakia
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Unverified
Germany
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Unverified
Poland
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Unverified
Lithuania
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Unverified
Bulgaria

Common questions

What is Major Depressive Disorder?

Major Depressive Disorder is a serious medical illness where you experience persistent feelings of sadness, loss of interest, and other symptoms that affect your daily life for a long time.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps us see if the new medicine works better than no treatment at all.

What does 'double-blind' mean?

Double-blind means that neither you (the participant) nor your study doctor will know whether you are receiving the real medicine or the placebo. This helps make the study results fair.

Will I know if the medicine helps me?

During the study, your doctors will monitor your mood and symptoms closely. However, the full results aren't known until the study is complete, and everyone is 'unblinded'.

How long will I take the study capsules?

You will take the study capsules twice a day for 8 weeks during the 14-week study period.