Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder - SM-1

This research is investigating a new treatment called REL-1017 for individuals living with major depression. This condition can make everyday life very difficult. The study focuses on people who haven’t fully responded to their current antidepressant medication. Researchers want to see if adding REL-1017 helps improve their symptoms more effectively than a placebo (a dummy pill). Both groups will receive identical-looking tablets, and neither the participants nor their doctors will know who is getting the real drug until the study ends. This is a common and important way to fairly test new medicines. The main aim is to see if REL-1017 helps reduce depression symptoms over 28 days.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Mggm LLC

Enrolment target

130

Start

08 May 2024

Major Depression

What is this study about?

When someone has major depression, it can be really tough, and sometimes the usual treatments don't work as well as everyone hopes. This study is for adults who are still struggling with their depression even though they're already taking medication for it. It's called a "Phase 3" study, which means it's one of the final steps in checking if a new treatment is safe and actually works before it can be made widely available.

The new medication being tested is called REL-1017. Participants in the study will be split into different groups by chance. Some will receive REL-1017, and others will get a placebo, which looks exactly the same but doesn't contain any active medicine. This is important so that scientists can compare the effects of the new drug fairly. Neither the participants nor their healthcare team will know who is getting which tablet until the study is over.

The main goal of the study is to measure whether REL-1017 helps to lessen the symptoms of depression over 28 days, compared to the placebo. Researchers will use special questionnaires and scales to track changes in mood, daily activities, and overall well-being. They will also keep a close eye on any side effects to make sure the treatment is safe.

Key takeaways

This study is testing a new drug for major depression.
It's for people whose current depression treatment isn't working well enough.
Participants will receive either the new drug or a dummy pill (placebo).
The study measures changes in depression symptoms over 28 days.
Close medical monitoring for safety and effectiveness is part of the process.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with major depression. You would be considered if your current antidepressant treatment hasn't helped you enough, meaning you're still experiencing significant symptoms of depression.

There might be other health conditions or medications that would prevent someone from joining, as these could affect the study's results or your safety. The research team will carefully review your full medical history to confirm if this study is suitable for you.

Basically, if you're an adult struggling with ongoing major depression despite current treatment, you might be a good fit to learn more about this study.

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 depression?
Are you currently taking medication for depression that hasn't fully helped?
Are you willing to attend regular clinic visits and take study medication for 28 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given tablets to take regularly for 28 days. These tablets will either be the new study medication, REL-1017, or a placebo (a dummy pill). You won't know which one you're receiving. Throughout the study, you'll have several visits to the clinic where you'll answer questions about your mood and how you're feeling. This will usually involve completing questionnaires, such as those that measure your depression symptoms and your ability to carry out daily activities. You might also have physical check-ups, blood tests, and have your vital signs (like blood pressure and heart rate) monitored. The research team will be checking for any side effects and how your body is responding to the treatment. There will be at least one follow-up visit after you stop taking the medication. The total duration of your active involvement in the study, including all visits and follow-ups, will be explained in detail.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical attention from a dedicated team. This might lead to an improvement in your depression symptoms. However, like all medications, REL-1017 could have side effects, which might be mild, serious, or unexpected. There's also a chance you might receive the placebo and not the active drug. You have the full right 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
Italy

Common questions

What is major depression?

Major depression is a serious mood disorder that causes a persistent feeling of sadness and loss of interest. It can affect how you feel, think, and behave, making it hard to do daily activities.

What is a 'Phase 3' study?

A Phase 3 study is one of the final stages of research where a new medicine is tested on a larger group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments or a placebo.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medication but contains no active drug. It helps researchers fairly test if the new medicine is actually working.

Will I know if I'm getting the real drug?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving REL-1017 or the placebo until the study is over. This helps ensure fair and unbiased results.

How long does the study last?

The main treatment period is 28 days, during which you'll take the study medication. There will also be several clinic visits and follow-ups, which the study team will explain in full detail.