Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])

The IMPACT-1 study is an important early-stage trial investigating a new medication called Methylone for individuals living with Post-Traumatic Stress Disorder (PTSD). This research is split into two main parts. The first part focuses on safety, carefully monitoring for any side effects and how the body reacts to Methylone. This involves checking things like heart rate, blood pressure, and blood tests. The second part aims to understand if Methylone can help reduce PTSD symptoms more effectively than a dummy treatment (placebo). Researchers will use special questionnaires to measure improvements. The goal is to see if Methylone could be a helpful new option for people affected by PTSD.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Transcend Therapeutics Inc.

Enrolment target

Start

26 Sep 2023

Post-Traumatic Stress Disorder (PTSD)

What is this study about?

This study, called IMPACT-1, is an important step in finding new ways to help people who have Post-Traumatic Stress Disorder, often called PTSD. PTSD can happen after someone goes through or sees a very shocking, frightening, or dangerous event.

The researchers are looking at a new medication called Methylone. This isn't a treatment that's ready for general use yet; it's still in the early stages of testing. Think of it like a new recipe – first, you try it out to make sure it's safe to eat, and then you see if it tastes good. In this study, the 'safety' part involves checking for any side effects and how the body handles the medicine. The 'tastes good' part means seeing if it helps reduce the difficult symptoms of PTSD.

This study combines two phases: Phase I and Phase II. Phase I is mostly about safety – making sure the medicine is well-tolerated and understanding its effects on the body. Phase II is about looking more closely at how effective the medicine might be in treating PTSD symptoms compared to a placebo (a dummy pill with no active ingredient). By carefully studying these things, scientists hope to learn if Methylone could potentially become a helpful new treatment option in the future.

Key takeaways

This study is testing a new medication, Methylone, for PTSD.
It's an early-stage study focusing on both safety and potential effectiveness.
Participation involves taking capsules and regular health checks.
The study lasts about 10 weeks.
You might receive the active drug or a placebo.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged at least 18 years old. People of any gender can take part.

You would also need to have a formal diagnosis of Post-Traumatic Stress Disorder (PTSD). The study has specific medical requirements to make sure it's safe for everyone involved. For example, there might be certain health conditions or medications that would prevent someone from joining, as these could affect how the study medicine works or make it unsafe.

The research team will carry out several checks and assessments during a screening visit to confirm if the study is suitable for you. They will explain all the requirements in detail.

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 attend clinic visits over a 10-week period?
Are you willing to take an oral capsule and have regular health checks?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the clinic over a period of about 10 weeks. During these visits, you would receive the study medication, Methylone, in a capsule form. Sometimes you might receive a capsule containing no active medication (a placebo), but you wouldn't know which one you're getting. You would have your vital signs, like heart rate and blood pressure, checked regularly, and you'd have blood and urine tests. You would also complete questionnaires about your PTSD symptoms and general well-being. These assessments help the doctors understand how you're feeling and how the medicine might be affecting you. There will be careful monitoring for any side effects throughout your participation. The research team will explain the full schedule of visits and assessments to you in detail.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to scientific understanding and potentially helping future patients with PTSD. You might also experience an improvement in your symptoms, though this is not guaranteed, as the treatment is still experimental. However, as with any new medication, there are potential risks, including side effects from Methylone or the possibility that it might not help your symptoms. The research team will carefully monitor you for any adverse effects. Remember, joining a clinical trial is always voluntary, and 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 stands for Post-Traumatic Stress Disorder. It's a mental health condition that some people develop after experiencing or witnessing a shocking, scary, or dangerous event.

What is Methylone?

Methylone is the name of the investigational medication being studied. It's not currently approved for use, and this study is looking into how safe and effective it might be for PTSD.

What does 'Phase I and Phase II' mean?

These are stages of clinical research. Phase I focuses on safety, and Phase II looks at whether the treatment works effectively, often compared to a placebo. This study combines aspects of both.

Will I definitely get the active medication?

In some parts of the study, participants might receive a placebo (dummy pill) instead of Methylone. This helps researchers understand the true effects of the study drug.

How long will the study last for me?

Your involvement in the study would last for about 10 weeks, with several visits during that time.