Evaluation of the effectiveness of the reconsolidation therapy in a clinical population suffering from post-traumatic stress disorder

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hopital Erasme

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04], Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

4 Oct 2023 → ongoing

Decision date (initial)

2023-02-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To verify the effectiveness of reconsolidation therapy in patients with a chronic and severe form of PTSD requiring hospital care. This verification will be carried out by comparing reconsolidation therapy to prolonged exposure therapy (Foa et al., 2000), recommended by the guidelines (APA, 2017; NICE, 2018) and the therapy "usually" offered within of the psychiatric care unit. To check if propranolol has an action of facilitator of extinction of the fear conditioning by including in the methodology a therapeutic group where patients would benefit prolonged exposure therapy plus propranolol intake to be compared with a therapeutic group where patients would benefit prolonged exposure therapy (without propranolol).

Secondary objectives 3

1. 1. To assess the benefits of reconsolidation therapy on symptoms commonly associated with PTSD, namely, anxiety, depression, emotional vulnerability, and emotional regulation skills.
2. 2. Evaluate the different treatments offered through the physiological index of heart rate variability (HRV). This is considered a valid biomarker for evaluating the autonomic nervous system, including that of people suffering from PTSD (Ge, Yuan, Li and Zhang; 2020). Effective treatment should alleviate the symptoms of hyperreactivity and reliving and thus elevate the HRV index (Grupe et al, 2018; Gillie and Thyer, 2014).
3. 3. To test the hypothesis that therapies offering propranolol will facilitate trauma work by making it more bearable due to its regulatory action on the overactivation of the sympathetic nervous system during reevocation or exposure sessions compared to the group PE and control. Endpoint: PANAS.

Conditions and MedDRA coding

Post-traumatic stress disorder

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Aged 18 to 65
2. Hospitalized in a psychiatric care unit
3. French mother tongue
4. Diagnosed with a state of post-traumatic stress marked by one or more traumas. Patients with PTSD who present with behavioral disorders characterized by difficulty regulating emotions, impulsivity, interpersonal difficulties, feelings of chronic emptiness and abandonment as well as dissociative symptoms are also included in the protocol of research.
5. Women of childbearing potential must be on hormonal contraception or a non-hormonal intrauterine device. Contraception must be maintained throughout the clinical sessions. Inclusion will be after a negative high sensitivity pregnancy test.

Exclusion criteria 10

1. Participants with unstabilized bipolar disorder and/or unstabilized substance dependance and/or with psychiatric disorders like schizophrenia.
2. Patients with neurological disorders or cognitive deficits measured by an M.M.S.E. score of less than 27 were not included in the study.
3. Pregnant or lactating women
4. Asthma, heart problems, diabetes
5. Basal systolic blood pressure < 100mm Hg
6. Basal heart rate <55 beats per minute
7. Previous adverse reaction to a beta-blocker or use of another beta-blocker
8. Participants are also evaluated by a psychiatrist to rule out any dangerous interaction between taking psychotropic drugs and propranolol.
9. Participants meet with a general physician in order to carry out medical check-up and to exclude any risk to taking propranolol
10. All contraindications mentioned in section 4.3 of the SmPC.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PCL-S: Posttraumatic stress disorder Checklist Scale.

Secondary endpoints 4

1. PANAS: Positive And Negative Affect Schedule.
2. HADs: Hospital Anxiety and Depression scale.
3. DERS: Difficulties in Emotion Regulation Scale.
4. HRV: Heart Rate Variability by a clock Polar V800.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hopital Erasme

Sponsor organisation

Hopital Erasme

Address

Lennikse Baan 808

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

Hopital Erasme

Contact name

Sabine Cornelis

Public contact point

Organisation

Hopital Erasme

Contact name

Sabine Cornelis

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

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