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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004653-32 | EudraCT Number |
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After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prazosin, ALPRESSĀ® LP 2,5 et 5 mg | Experimental | Patients included in this study will be adults with acute stress as a result of a direct experience traumatic event. They will be treated with Prazosin, ALPRESSĀ® LP 2,5 et 5 mg during 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazosin, ALPRESSĀ® LP 2,5 et 5 mg | Drug | Patients will take Prazosin during 28 days ; there are two periods of treatment (escalation of doses):
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| Measure | Description | Time Frame |
|---|---|---|
| PTSD diagnosis | The Presence of PTSD diagnosis will be assessed by the Clinician Administered PTSD Scale (CAPS) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute stress symptoms | These symptoms are assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria | 14 days |
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department | Lyon | 69003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38154074 | Result | Magnin C, Poulet E, Fanton L, Vignaud P, Brunelin J. A non-randomized pilot trial of the use of prazosin in the prevention of transition from acute stress disorder to post-traumatic stress disorder. Eur J Psychotraumatol. 2023;14(2):2251250. doi: 10.1080/20008066.2023.2251250. Epub 2023 Sep 6. |
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| ID | Term |
|---|---|
| D040701 | Stress Disorders, Traumatic, Acute |
| D013313 | Stress Disorders, Post-Traumatic |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 7 days |
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test | 14 days |
| Prazosin side effects | This will be investigated using a self questionnaire about frequent side effects due to Prazosin, measurement of blood pressure, and orthostatic hypotension test | 1 month |
| occurrence of complications of PTSD | Complications of PTSD are attempted suicide, suicidal ideation, addiction, depression and quality of life. | 6 months |
| Compliance | Compliance will be evaluated by counting the tablets consumed and not consumed at the end of the treatment by Prazosin | 1 month |