A Phase 3 interventional study of Propranolol and Psychotherapy in Post-Traumatic Stress Disorder, PTSD, sponsored by University Hospital, Toulouse. Not yet recruiting at 2 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University Hospital, Toulouse · Phase 3, Interventional, and Treatment
Post-traumatic stress disorder (PTSD) develops after life-threatening events, with domestic violence and sexual assault being major risk factors. An innovative approach using traumatic memory reactivation with propranolol has shown promise in reducing PTSD symptoms. This study aims to compare the efficacy of propranolol with trauma-focused psychotherapy in women suffering from severe PTSD after violence.
Post-traumatic stress disorder (PTSD) develops following exposure to a life-threatening event. Being a victim of domestic physical violence and/or sexual assaults is among the highest risk factors for developing PTSD (Darves-Bornoz et al., 2008). The World Health Organization (WHO) recommends trauma-focused psychotherapy (such as PE) as the most effective treatment for PTSD. However, these treatments can be costly and difficult to access. Recently, PTSD treatment involving traumatic memory reactivation procedure combined with Propranolol - a widely used beta-blocker - has demonstrated both safety and efficacy. Given that PTSD is characterized by emotional hypermnesia of the traumatic memory, this approach aims to reduce PTSD symptoms severity by attenuating the emotional charge associated with the traumatic memory. The primary objective of our study is to compare the efficacy of Propranolol with Prolonged Exposure/PE in women who have experienced violence and suffer from severe PTSD.
In the propranolol group, for the first session, ninety minutes after propranolol ingestion, participants write a one-page trauma narrative script focusing on the event's most disturbing moments. The five following sessions consist of lecture of the traumatic script after ingestion of propranolol.
In the psychotherapy group, PE is standardly realized during eight to ten sessions.
A follow-up session is scheduled three months after the treatment for both groups.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 167 interventional studies indexed under Combat Disorders.
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Exclusion Criteria:
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Drug: Propranolol
Behavioral: Psychotherapy
The first treatment session consists of preparing the traumatic script. Ninety minutes after taking propranolol, the preparation of the traumatic scenario will be conducted by a trained psychologist at the center. This standardized procedure (CHU de Toulouse, 2022) involves asking the patient to write a report on the most distressing aspects of the traumatic event, incorporating as many sensory modalities as possible (visual, olfactory, auditory elements, etc.) and episodic details (such as location, time, season, people present, etc.). This first session lasts approximately 30 minutes. The report will then be briefly discussed with the participant to ensure it contains sufficient detail. This "traumatic scenario" will be typed by the psychologist, resulting in a one-page script, which the subject will read during sessions 2 to 6 for memory reactivation. These five subsequent sessions last approximately 10 minutes each.
After randomization, participants in the "psychotherapy group" will receive PE. The eight to ten PE sessions follow classical and operant conditioning principles, emphasizing habituation. They use imaginal exposure, applied with progressivity and repetition, ensuring prolonged and complete exposure. Each session lasts 45 minutes.
Effect of traumatic memory reactivation under propranolol in women who are victims of violence and suffer from PTSD
It will be assessed by the PTSD symptom score on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) administered 1 week after the last psychotherapy session (V7 for propranolol group or V9 for for psychotherapy group). The CAPS-5 scale is a 45 to 60-minutes structured interview that assesses the frequency and severity of each PTSD symptom related to a traumatic event. It provides a diagnosis of PTSD as well as a PTSD symptom severity score (0 to 80) and an intrusion symptom severity score (0 to 25).
Time frame: 7 weeks (propranolol group) or 9 weeks (psychotherapy group)
Number of sessions
The PTSD symptom score on the Clinician-Administered PSTD Scale for DSM-5 (CAPS-5) will be used to evaluate the effect of 6 sessions PPNL in comparison with 6 sessions PE. It will be assessed 1 week after the 6th session, on V7.
Time frame: 7 weeks
Stability of the treatment effect
The PTSD symptom scores on the CAPS-5 at S1, M3, and M6 will be used to assess the stability of the treatment effect.
Time frame: 6 months
Percentage of cases not remitted
The percentage of female patients with a clinical diagnosis of PTSD 1 week, 3 months, and 6 months after the last treatment session, as recommended by the DSM-5 and assessed using the CAPS-5 will be used to evaluate the cases not remitted.
Time frame: 6 months
Perceived intensity
It will be assessed by the score measured by the PTSD Checklist-5 (PCL-5) self-report questionnaire administered at V7 (propranolol and PE group), V9 (PE group), M3, and M6 following the last PPNL session and the last PE sessions. The PCL-5 is a 20-item self-report questionnaire used to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms according to the DSM-5 criteria. Each item is scored on a scale of 0 to 4, for a total score ranging from 0 to 80 (where 0 indicates no symptoms and 80 indicates the presence of all symptoms).
Time frame: 6 months
Symptoms of depression
They will be assessed by the depression symptom scores on the 21-item Beck Depression Inventory, Version II (BDI-II) at S7, M3, and M6. The BDI-II is a 21-item self-report questionnaire used to assess the severity of depressive symptoms in adolescents and adults, yielding a total score ranging from 0 to 63 (0 = no or very few depressive symptoms, 63 = maximum level of symptoms).
Time frame: 6 months
Symptoms of dissociation
They will be assessed by the dissociative symptom scores on the Dissociative Experiences Scale (DES) at S7, M3, and M6. The DES is a 28-item self-report questionnaire that assesses the frequency of dissociative experiences. Each item is rated on a scale from 0 to 100 percent, depending on how often the described experience occurs. The total score is the average of the 28 items and therefore also ranges from 0 to 100 (\<20 = low level of dissociation, 20-30 = moderate level, and \>30 = high level).
Time frame: 6 months
Suicidal ideation
It will be assessed by the scores on the suicidal ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS) at S7, M3, and M6. The C-SSRS is a clinical scale used to assess suicidal thoughts and behaviors. In particular, it assesses: the presence of suicidal thoughts, their intensity and frequency, the existence of a suicide plan or intent, suicide attempts and other suicidal behaviors, and certain preparatory behaviors. It uses a scale ranging from 1 to 5; the higher the level, the more concerning the risk of suicide.
Time frame: 6 months
Adverse events
The adverse events (AEs) and serious AEs occurring during the 6-month follow-up period will be collected.
Time frame: 6 months
Functionnal improvement
It will be assessed by the Clinical Global Impression Improvement Scale (CGI-I) score at M3 and M6. The CGI is a clinical assessment used to provide an overall evaluation of a patient's condition and/or progress during treatment. It consists of two dimensions: severity and improvement, each rated on a scale of 7 (where 1 corresponds to normal/significantly improved and 7 to extremely ill/significantly worsened).
Time frame: 6 months
Perceived quality of life
It will be assessed by the World Health Organization Quality of Life Brief (WHO-QOL) score, translated into French, at S7, M3, and M6. The WHO-QOL is a questionnaire consisting of 26 items that assess physical and psychological health, social relationships, and the environment. It evaluates the overall impact of health status on daily life.
Time frame: 6 months
Start is estimated for Dec 2026; primary completion for Mar 2030, 39 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Propranolol
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