A Phase 2 interventional study of Propranolol, 120mg and Placebo in PTSD - Post Traumatic Stress Disorder, sponsored by University Hospital, Tours. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by University Hospital, Tours · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to evaluate the effect of early propranolol administration on the occurrence of post-traumatic stress disorder (PTSD) symptoms at five weeks in adult female victims of sexual violence.
The investigators hypothesize that propranolol administration may reduce the traumatic emotional experience associated with the memory by positively modulating neurovegetative symptoms during the memory reconsolidation phase, thereby decreasing the risk of developing post-traumatic stress disorder (PTSD). This specific context of sexual violence appears particularly suitable, given the timeline of events, to evaluate the pharmacological efficacy of propranolol on memory reconsolidation and the prevention of post-traumatic symptom development.
Participants will :
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 34 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Propranolol, 120mg
Drug: Placebo
The experimental group will receive propranolol administered orally at a total daily dose of 120 mg, divided into three daily doses of 40 mg for 10 days, followed by a tapering phase consisting of two daily doses of 40 mg for 7 days, and then a single daily dose of 40 mg per day for an additional 7 days.
The control group will receive a placebo in the form of capsules identical in appearance to the active treatment and administered according to the same dosing regimen as the experimental group.
Participant rate with post-traumatic stress disorder symptoms.
Assessed using the CAPS-5 scale (Clinician Administered PTSD Scale for Diagnostic and Statistical manual of mental disorders - Fifth edition) The diagnosis of post-traumatic stress disorder (PTSD) will be defined in the presence of: * At least 1 item from the intrusive symptoms (cluster B) * At least 1 item from the avoidance symptoms (cluster C) * At least 2 items from the cognitive and mood symptoms (cluster D) * At least 2 items from the arousal and reactivity symptoms (cluster E). In addition, the total score for clusters B + C + D + E must be at least 20 points. The severity of PTSD (post-traumatic stress disorder) is assessed by adding up the scores for the 20 post-traumatic symptoms and dividing the total by 20.
Time frame: 5 weeks
Post-traumatic symptoms
Assessed using a semi-structured diagnostic interview administered by a clinician : CAPS-5 : Clinician Administered PTSD (post-traumatic stress disorder) Scale for the Diagnostic And Statistical Manual of Mental Disorders -Fifth edition
Time frame: 5-weeks
Post-traumatic and depressive symptoms
Assessed using PCL-5 (Posttraumatic Stress Disorder Checklist for Diagnostic And Statistical Manual of Mental Disorders -Fifth edition)
Time frame: at 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using IES-R questionnaire (Impact of Event Scale - Revised)
Time frame: 5-weeks, 3-months and 6-months
Post-traumatic and depressive symptoms
Assessed using PHQ-9 questionnaire (Patient Health Questionnaire)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using FAST questionnaire (Functional Assessment Staging Tool)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using GAF questionnaire (Global Assessment of Functioning)
Time frame: 5-weeks, 3-months and 6-months
Impact on individual performance
Assessed using VAS scale (Visual Analog Scale of Health Status)
Time frame: 5-weeks, 3-months and 6-months
Costs associated with healthcare consumption
Time frame: Since Day 0 to 6-Months
Sick leave
Time frame: Since Day 0 to 6-Months
Suicide risk
Assessed using C-SSRS (colombia - Suicide severity rating scale)
Time frame: At 5-weeks, 3-months and 6-months
Recording of adverse events
Time frame: From Day 0 to the end of the follow-up
No study locations are listed for this record.
Plan to share: Yes — The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2027, 13 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Propranolol