Women victims of violences : PTSD treatment by traumatic memory reactivation under the influence of propranolol (VIOFEM)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Decision date (initial)

2026-06-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate, in a group of women who are victims of violence and suffer from PTSD, the effect of treatment consisting of 6 sessions (1 per week) of traumatic memory reactivation under propranolol/PPNL (a single dose of propranolol administered prior to the traumatic memory reactivation) compared to the effect of treatment with 8 sessions (1 per week) of prolonged exposure psychotherapy (EP) on PTSD symptoms.

Secondary objectives 12

1. To evaluate, in a group of women who are victims of violence and suffer from PTSD, the effect of treatment consisting of 6 sessions (1 per week) of traumatic memory reactivation under propranolol/PPNL and the effect of treatment consisting of 6 sessions (1 per week) of prolonged exposure psychotherapy/EP, one week after the last treatment session (S7).
2. Assess the stability of the effect on PTSD symptoms of the 6 treatment sessions 3 months and 6 months after the 6th session.
3. Assess the percentage of non-remission (PTSD cases) after 6 treatment sessions, 1 week, 3 months, and 6 months after the 6th session.
4. EAssess the effect of the 6 treatment sessions on comorbid depressive symptoms, 1 week, 3 months, and 6 months after the 6th session.
5. Assess the effect of the 6 treatment sessions on comorbid dissociative symptoms, 1 week, 3 months, and 6 months after the 6th session.
6. Assess the effect of the 6 treatment sessions on suicidal ideation, 1 week, 3 months, and 6 months after the 6th session.
7. Assess the effect of the 6 treatment sessions on comorbid depressive symptoms, 1 week/W7, 3 months/M3, and 6 months/M6 after the last session.
8. Assess the effect of the 6 treatment sessions on comorbid dissociative symptoms 1 week (W7), 3 months (M3), and 6 months (M6) after the last session.
9. Assess treatment tolerance
10. Assess the effect of the 6 treatment sessions on the participant’s subjective perception of functional improvement in their overall clinical condition, 1 week (W1), 3 months (M3), and 6 months (M6) after the last session.
11. Assess the effect of the 6 sessions on the participant’s perceived quality of life, 1 week (W7), 3 months (M3), and 6 months (M6) after the last session
12. Evaluate the effect of treatment with 6 sessions (1 per week) of traumatic memory reactivation under propranolol/PPNL and the effect of treatment with 8 sessions (1 per week) of prolonged exposure psychotherapy/PE on the perceived intensity of PTSD symptoms. traitement par 8 séances (1 par semaine) de psychothérapie par exposition prolongée/EP, sur l’intensité perçue des symptômes du TSPT

Conditions and MedDRA coding

Post-traumatic stress disorder (PTSD)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Women aged from 18 to 75 years
2. Having been victim of severe violence (rape, sexual assault, physical assault)
3. Currently suffering from PTSD related to the traumatic event. The diagnosis of PTSD is made according to the DSM-5 criteria by a psychiatrist/psychologist using the CAPS-5, regardless of the traumatic event meeting criterion A of the DSM-5, with or without dissociative symptoms as described in the “With dissociative symptoms” section of the DSM-5, Immediate or delayed PTSD
4. heart rate ≥ 55 bpm
5. The subject must have signed the consent form.
6. The subject must be enrolled in a social security program.
7. The participant must be able to understand and read French.
8. The participant agrees to comply with the contraception requirements outlined in the protocol
9. CAPS-5 total score ≥ 33

Exclusion criteria 21

1. Systolic blood pressure below 100 mm Hg.
2. USevere psychiatric disorders: Severe symptoms of other anxiety disorders, severe symptoms of Obsessive-Compulsive Disorder, history of or current psychotic disorder, bipolar mood disorder, severe personality disorder, alcohol or other substance use disorder
3. “Yes” response to item 4 of the C-SSRS: active suicidal ideation with intent to act, without a specific plan, and/or “Yes” response to item 5 of the C-SSRS: active suicidal ideation with a specific plan and intent to act
4. Propanolol contrindications
5. Heart failure (compensated or decompensated)
6. Severe liver disease
7. Significant renal impairment
8. Myasthenia gravis
9. Personal or family history of psoriasis
10. Patients who have suffered a head injury within the past year or who have clinical symptoms and residual neurological sequelae
11. Wearing contact lenses
12. Hospitalized or treated for suicidal behavior within the past 3 months
13. Previous intolerance to a beta-blocker.
14. Women of childbearing age not using contraception
15. Pregnancy, breastfeeding
16. Current use of a beta-blocker, regardless of the formulation.
17. Known interactions with Propranolol (combination use not recommended and combinations to be used with caution) as indicated in the summary of product characteristics
18. Undergoing psychotherapy or pharmacological treatment with psychotropic agents such as antidepressants, neuroleptics, and/or mood stabilizers. However, these subjects may be included after a 2-week therapeutic abstinence period (6 weeks for treatment with fluoxetine).
19. Patients under judicial protection, under guardianship or curatorship, individuals under family authorization, or under a future protection order with representation regarding the person
20. Participants who are related to a person involved in the study at the investigator’s center, within the clinical research organization (CRO), or at the sponsor
21. Participation in another interventional research study, clinical trial, or clinical investigation within the 6 months preceding selection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PTSD symptom score at the Clinician Administered PTSD Scale for DSM-5/CAPS-5 (Rivest-Beauregard et al., 2022) administered one week/S7 after the 6th and last PPNL session and one week/S9 after the 8th and last PE session.

Secondary endpoints 10

1. In order to evaluate the effect of 6 PPNL sessions compared to 6 PE sessions, the judgment criterion will be the quantitative variable corresponding for each subject to the PTSD symptom score at CAPS-5 administered one week/S7 after the 6th treatment session.
2. STABILITY OF THE TREATMENT EFFECT In order to evaluate the stability of the effect of the 6 treatment sessions 3 and 6 months after the 6th session, a secondary endpoint will be the quantitative variable corresponding to the PTSD symptom score at CAPS-5 at S1, at M3, and at M6.
3. PERCENTAGE OF NON-REMISSION In order to evaluate the percentage of non-remission after 6 treatment sessions, 1 week, 3 and 6 months after the 6th treatment session, a secondary endpoint will be the percentage of patients with a clinical diagnosis of PTSD 1 week, 3 and 6 months after the last treatment session, as recommended by DSM-5 and evaluated using CAPS-5.
4. SYMPTOMS OF DEPRESSION In order to evaluate the effect of the 6 treatment sessions on comorbid depression symptoms, 1 week, 3 and 6 months after the 6th session, a secondary endpoint will be the quantitative variable corresponding to the depression symptom score at Beck Depression Inventory version II 21 items (BDI-II; Beck et al., 1998) at S7, M3 and M6.
5. DISSOCIATIVE SYMPTOMS In order to evaluate the effect of 6 treatment sessions on comorbid dissociative symptoms, 1 week, 3 and 6 months after the 6th session, a secondary outcome will be the quantitative variable corresponding to the score of dissociative symptoms on the Dissociative Experiences Scale. (DES; Darves-Bornoz et al., 1999) to S7, M3 and M6.
6. SUICIDAL IDEATION In order to evaluate the effect of the 6 treatment sessions on suicidal ideation, 1 week, 3 and 6 months after the 6th session, a secondary endpoint will be the quantitative variable corresponding to the score on the subscale suicide ideation of the Columbia scale-Suicide Severity Rating Scale (C-SSRS) (Posner et al., 2011) at S7, M3 and M6.
7. Adverse effects : In order to assess the safety of the treatment, adverse events (AEs) and serious AEs occurring during the 6-month follow-up period will be recorded.
8. FUNCTIONAL IMPROVEMENT In order to evaluate the effect of the 6 treatment sessions on the participant’s functional improvement, at the end of the 6th session and 3 months and 6 months later, a secondary endpoint will be the quantitative variable corresponding to the Clinical Global score. Impression Improvement Scale (CGI-I, Busner et al., 2007) at M3 and M6.
9. QUALITY OF LIFE With the aim of evaluating the effect of the 6 treatment sessions on the quality of life of the participants, 1 week, 3 months and 6 months after the 6th treatment session, a secondary judgment criterion will be the corresponding quantitative variable auscore of the World Health Organization Quality of Life Brief (WHOQUOL, The WHOQOL Group, 1998) translated into French, at S7, M3 and M6.
10. In order to assess the effect of 6 PPNL sessions compared to 8 PE sessions on the perceived intensity of PTSD symptoms, the judgment criterion will be the quantitative variable corresponding to the score measured by the PCL self-questionnaire.5 administered one week/S7 after the 6th and last PPNL session and one week/S9 after the 8th and last PE session.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie

City

Toulouse

Postcode

31300

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Pr Philippe BIRMES

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

Delphine VERNET

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications