Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

This study is testing a new medicine called Methylone, given as a capsule, for adults diagnosed with Post-Traumatic Stress Disorder (PTSD). Scientists want to see how well it works to reduce PTSD symptoms over a year and if it’s safe. They’ll be looking at things like how much PTSD symptoms improve, as well as mood, sleep, and overall well-being. Participants will receive either single or repeated doses of Methylone. This is an early-stage study, meaning researchers are trying to understand the drug better before it can become a standard treatment. The goal is to provide a new option for people living with PTSD.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Transcend Therapeutics Inc.

Enrolment target

Start

05 Apr 2024

Post-Traumatic Stress Disorder

What is this study about?

This study is about a medicine called Methylone, which is being tested as a possible new treatment for Post-Traumatic Stress Disorder, often called PTSD. PTSD is a condition that can develop after someone experiences or witnesses a very frightening, shocking, or distressing event. It can cause upsetting thoughts, feelings, and memories related to the event, even long after it has happened.

The main goal of this particular study is to find out if taking Methylone, in a 50 mg capsule, can help reduce the symptoms of PTSD. The research team also wants to make sure that the medicine is safe to use over a longer period, up to a year. They're looking at different ways to measure how well people feel, including their PTSD symptoms, mood, how well they sleep, and their general quality of life and mental well-being.

This is a 'Phase II' study, which means it's still in the earlier stages. Researchers are exploring if the medicine works and if it has any side effects, before it can be considered for wider use. The information gathered from this study will help us understand if Methylone could be a helpful treatment option for people with PTSD in the future.

Key takeaways

This study is testing a new medicine called Methylone for PTSD.
It aims to see how well it works and if it's safe over a year.
Participants will receive Methylone capsules and have regular health checks.
The study is for adults aged 18 and over who have PTSD.
It's an early-stage study to gather more information about the treatment.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Since this study focuses on Post-Traumatic Stress Disorder, you would need to have received a diagnosis for this condition from a doctor. This is to ensure the medicine is tested on the people it's intended to help.

The research team will also check for other health conditions or medicines you might be taking to make sure it's safe for you to participate. These checks are important for everyone's safety during the trial.

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 Post-Traumatic Stress Disorder (PTSD)?
Are you able to commit to around a year of study visits and follow-up?
Do you understand that you will receive an experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Methylone, in a 50 mg capsule. The study will last for about a year (52 weeks). During this time, you will have regular visits to the clinic. These visits will involve various checks and assessments to see how you are feeling and how the medicine is affecting your PTSD symptoms, mood, and sleep. You'll also have tests like blood pressure checks, blood tests, and heart tests (ECG) to monitor your health and safety. You will be asked about any side effects you might experience. Throughout the study, you'll be closely monitored by the study team, and they will be there to support you and answer any questions.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new, experimental treatment for your PTSD and having regular, close medical supervision. However, there are also potential risks, including side effects from the medicine, which could be mild or more serious. It's also possible that the medicine may not work for you, or it might not work as well as existing treatments. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Ireland

Common questions

What is PTSD?

PTSD, or Post-Traumatic Stress Disorder, is a condition that can develop after someone experiences or witnesses a very frightening or distressing event. It can lead to flashbacks, nightmares, and severe anxiety.

What is Methylone?

Methylone is the name of the experimental medicine being tested in this study. It's given as a capsule to see if it can help reduce PTSD symptoms.

How long will the study last?

The study is designed to last for about a year (52 weeks) so researchers can see the longer-term effects of the medicine.

Will I know if I'm getting the actual medicine?

This particular study is 'open-label', which means both you and the study doctors will know you are receiving Methylone. There is no placebo group in this specific trial.

Are there any side effects?

Like all medicines, Methylone may have side effects. The study team will carefully monitor you for any serious or non-serious side effects throughout your participation.