AuthorisedTherapeutic exploratory (Phase II)Interventional

Propranolol for early secondary prevention of post-traumatic stress disorder in female victims of sexual violence: a single-center, randomized, placebo-controlled pilot study - PPRESVISE

This study, called PPRESVISE, is investigating if a medicine called propranolol can help prevent post-traumatic stress disorder (PTSD) in women who have experienced sexual violence. Propranolol is a common medication often used for conditions like high blood pressure or anxiety. This is a "Phase II" study, which means it's an early step to see if the treatment has a positive effect and is safe. Participants will either receive propranolol or a dummy pill (placebo). Researchers will regularly check for PTSD symptoms and how well participants are coping over six months. The aim is to find out if giving propranolol soon after a traumatic event could reduce the chances of developing PTSD.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

Start

17 Feb 2025

Prevention of post-traumatic stress disorder

What is this study about?

This study is exploring a new approach to help women who have experienced sexual violence. The main goal is to see if an existing medicine, propranolol, can prevent them from developing post-traumatic stress disorder (PTSD). PTSD is a condition that can develop after experiencing or witnessing a very frightening or distressing event. It can cause flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event.

The researchers want to know if giving propranolol shortly after such a traumatic event could reduce the risk of PTSD. Propranolol is a well-known medicine, often prescribed for things like managing high blood pressure or anxiety. For this study, some participants will receive propranolol tablets, while others will get a 'dummy pill' (called a placebo) that looks the same but contains no medicine. This helps researchers fairly compare the effects of the actual medicine.

This is a pilot study, meaning it's relatively small and designed to gather initial information. If the results are promising, it could lead to larger studies in the future. The hope is that this research might eventually provide an early treatment option to help reduce the long-term impact of traumatic experiences.

Key takeaways

This study investigates if propranolol can prevent PTSD after sexual violence.
It's an early-stage study to see if the treatment is safe and effective.
Participants will receive either propranolol or a dummy pill (placebo).
Your well-being and symptoms will be checked regularly over six months.
The study aims to find new ways to help people cope after trauma.

Who may be eligible?

To join this study, you must be a woman aged 18 or over. There is no upper age limit, so women of any age above 18 can potentially take part.

More specific details about your health and recent experiences would be discussed with the study team. You would need to meet certain health criteria to ensure the treatment is safe for you and that the study results are as clear as possible.

If you're interested, the research team would carefully review your medical history and current situation to see if the study is a good fit for you.

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 a woman aged 18 or older?
Have you recently experienced sexual violence?
Are you generally in good health, without conditions that would make propranolol unsafe?
Are you able to attend appointments over a six-month period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either propranolol tablets or a dummy pill (placebo). You wouldn’t know which one you're taking, nor would your study doctor, to keep the results fair. You would have several appointments over a period of six months. At these appointments, a healthcare professional would ask you questions about your well-being and any symptoms of PTSD. You would also complete some questionnaires on your own.

These checks happen at 5 weeks, 3 months, and 6 months after starting the study. The questions will cover how you're feeling, your symptoms, and how your daily life is affected. The study team will also keep track of any side effects you might experience. The total duration of your active involvement in the study would be six months.

Potential risks and benefits

Participating in this study might offer a potential benefit if propranolol helps to prevent PTSD after a traumatic event. However, as it's an early study, there's no guarantee that you will personally benefit. There are also potential risks, as propranolol can have side effects, like feeling tired, dizzy, or having a slow heartbeat. The study team will carefully monitor you for any side effects. It's important to remember that participating is entirely your choice. You can decide to leave 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
France

Common questions

What is PTSD?

PTSD, or Post-Traumatic Stress Disorder, can happen after a very frightening or distressing experience. It causes symptoms like flashbacks, nightmares, and feeling very anxious or on edge.

What is propranolol?

Propranolol is a common medicine often used for high blood pressure, anxiety, and even migraines. It works by blocking certain signals in your body.

Why use a 'dummy pill' (placebo)?

A dummy pill helps researchers fairly compare the actual medicine's effects. It ensures that any changes observed are truly due to the propranolol and not just the expectation of treatment.

How long will the study last for me?

If you join, your participation will involve appointments and monitoring over a total of six months.

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

No, neither you nor the doctors will know who is receiving the propranolol and who is receiving the dummy pill until after the study is over. This is to keep the results unbiased.