Study on Propranolol for Preventing PTSD in Women After Sexual Violence

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What is this study about?

This clinical trial is focused on the early prevention of post-traumatic stress disorder (PTSD) in women who have experienced sexual violence. The study will use a medication called Propranolol, which is commonly used to treat heart conditions but is being tested here for its potential to prevent PTSD symptoms. Participants in the study will receive either Propranolol or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate whether taking Propranolol soon after experiencing trauma can reduce the occurrence of PTSD symptoms. The study will follow participants over a period of time to observe any changes in their symptoms. Participants will be asked to take the medication and attend follow-up visits where their symptoms will be assessed using questionnaires and scales designed to measure PTSD and overall functioning.

Throughout the study, participants will be monitored for any side effects or adverse events. The study aims to provide valuable information on whether Propranolol can be an effective early intervention for preventing PTSD in women who have experienced sexual violence. The results could potentially lead to new treatment options for those at risk of developing PTSD after traumatic events.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, heart rate, and language proficiency, among other criteria.

2 medication administration

Participants receive Propranolol 40 mg film-coated tablets for oral use. The medication is administered as part of the study protocol to evaluate its effect on preventing post-traumatic stress disorder symptoms.

3 five-week evaluation

At five weeks, symptoms are assessed using the CAPS-5 scale, which is a tool used by clinicians to evaluate post-traumatic stress disorder symptoms.

4 self-assessment questionnaires

Participants complete self-assessment questionnaires at five weeks, three months, and six months. These questionnaires include the IES-R, PCL-5, and PHQ-9, which measure the impact of events, post-traumatic stress disorder symptoms, and general health, respectively.

5 functioning and health impact evaluation

The impact on individual functioning is evaluated at five weeks, three months, and six months using tools such as the FAST and GAF scales, along with a subjective visual analog scale of health status.

6 cost and risk evaluation

At three months, the study evaluates the costs associated with healthcare consumption and work absences. Additionally, suicide risk is assessed using the C-SSRS scale.

7 adverse events monitoring

Throughout the study, any adverse events experienced by participants are collected and documented.

Who Can Join the Study?

Must be a female (cisgender).
Heart rate must be at least 55 beats per minute (bpm).
Must be able to understand and read French.
Must be 18 years old or older.
Must agree to follow the contraceptive requirements as detailed in the study protocol.
Must have a systolic blood pressure greater than 10 cm Hg. Systolic blood pressure is the pressure in your blood vessels when your heart beats.
Must have been seen in a consultation for sexual violence at the Medico-Judicial Unit (UMJ) for touching and/or rape within 72 hours after the incident.
Must be affiliated with a social security system.
Must provide free, informed, and written consent signed by the participant.

Who Cannot Join the Study?

Men cannot participate in the study. Only women are eligible.
Individuals who are not adults cannot participate. Only adults are eligible.
People who are considered part of a vulnerable population cannot participate. This means individuals who might need special protection or care are not eligible.

Where you can join this trial?

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Site Name	City	Country	Status
Cskvdt Hwovvyxxnqa Rsydcfxh Ucdonvbzwfxxi Db Todns	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	06.01.2025

Trial locations

Investigated drugs:

Propranolol

Propranolol is a medication used in this study to see if it can help prevent symptoms of post-traumatic stress disorder (PTSD) in women who have experienced sexual violence. It is being tested to find out if taking it early can reduce the chances of developing PTSD symptoms after such traumatic events.

Investigated diseases:

Post-traumatic stress disorder

Post-Traumatic Stress Disorder – This mental health condition is triggered by experiencing or witnessing a traumatic event. It is characterized by symptoms such as flashbacks, nightmares, severe anxiety, and uncontrollable thoughts about the event. Over time, individuals may experience emotional numbness, avoidance of reminders of the trauma, and heightened reactions to stimuli. The disorder can disrupt daily life, affecting personal relationships and work. Symptoms can vary in intensity and may appear soon after the event or years later. The progression of the disorder can be influenced by factors such as the nature of the trauma, individual resilience, and support systems.

Trial ID:

2023-504075-25-00

Protocol code:

DR230070

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Propranolol for Preventing PTSD in Women After Sexual Violence

What is this study about?

Who Can Join the Study?

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