PTSDPhase 3PPPNCT04985344
Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol
A Phase 3 study testing Propranolol Oral Product and memory reactivation in people with PTSD, run by University Hospital, Toulouse at 1 site in France.
Trial summary
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- PTSD
- What is being tested?
- Propranolol Oral Product and memory reactivation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years
- CPTS-RI total score ≥40
- Primary diagnosis of PTSD (6 months or more after the traumatic event)
- Heart rate ≥ 55 bpm
- Systolic blood pressure ≥ 95 mm Hg
- Affiliation to a social security scheme
- Written consent signed by the parents/holders of parental authority and the investigator
- Acceptance of the protocol by the child-Child and Parents/Holders of parental authority fluent in French
Who cannot join
- Age<7 years or ≥13 years
- Children whose parents have been deprived of their authority
- Contraindication to propranolol (cardiogenic shock, sinus bradycardia, hypotension (< fifth percentile oscillometric or <2SD) (Banker et al., 2016 - see APPENDIX 1), greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
- Concurrent medication with possible interactions with propranolol (cf 8.2)
- Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD (Antidepressants, atypical antipsychotics, mood stabilizers)
- Concurrent psychotherapy (>1 structured session/month declared by the clinician who follows the child)
Show all 17Show fewer
- Current active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, attention-deficit hyperactivity disorder, autism spectrum disorder
- Children with psoriasis
- Children with a predisposition to hypoglycemia
- Obsessive-compulsive disorders
- Bipolar Disorders
- Mental retardation,
- Traumatic brain injury (loss of consciousness > 10 minutes)
- Currently treated with a bradycardic drug
- Concurrent participation to another interventional study
- Renal or Hepatic Impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Toulouse University Hospital
Toulouse, 31059
Philippe BIRMES, PH, 5 34 55 75 00 ext. +33, birmes.p@chu-toulouse.fr
Philippe BIRMES, PH
About this study
Official title: Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
Read the detailed description
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
The combination of the targeted reactivation of the traumatic memory and the intake of an agent that decreases the reconsolidation can thus disrupt the recall of unwanted memories and thus serve as a treatment for people suffering from traumatic memories, such as in PTSD.
Since stimulation of β-noradrenergic receptors facilitates the consolidation of memories as well as their re-consolidation, an antagonist of these receptors, propranolol, has generated considerable interest as a treatment to alleviate emotional and traumatic memories in individuals with PTSD.
In adults diagnosed with long-standing PTSD two 6-week, double-blind, placebocontrolled, randomised clinical trials, one in 60 subjects and the other in 67 have shown promising results. PTSD participants who actively recalled their traumatic event under the influence of propranolol once a week for up to 6 weeks showed a substantial decrease in symptom ratings compared with placebo. Thus, all of this data led the team to propose a comparable design study in children with PTSD
- Conditions
- PTSD
- Being tested
- Propranolol Oral Product, Placebo, memory reactivation
- Keywords
- PTSD, traumatic memory reactivation, pediatric, Propranolol, Post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol Oral ProductDrug
Also called Propranolol
Child will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance.
PlaceboDrug
Child will receive oral placebo (syrup). The dose of placebo will increase gradually over the first 3 treatment sessions in order to match propranolol intervention.
memory reactivationOther
90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Patient will receive oral propranolol Receives: Drug: Propranolol Oral Product; Other: memory reactivation |
| Placebo | Placebo comparator | Patient will receive oral placebo Receives: Drug: Placebo; Other: memory reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Post-Traumatic Stress Reaction Index/CPTS-RI
The main evaluation criterion will be the difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 8 and week 0. The CPTS-RI is a scale comprised of 20 Likert-type items, intended for children from 6 to 16 years, which evaluates the symptoms of PTSD after exposure to various traumatic events. Each item frequency is rated on a 5-point scale, from never (=0) to almost always (=4). The global score consists of the sum of the 20 items and ranges from 0 to 80, with higher scores indicating higher PTSD symptom severity. The time required for completion of the scale is 15-20 min. A total score of 12-24 is associated with a mild level of PTSD, from 25-39 with a moderate level, from 40-59 with a severe level, and ≥60 with a very severe level.
Measured: week 8
Secondary outcomes (20)
Child Post-Traumatic Stress Reaction - Week 32 Index/CPTS-RI
The difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score at week 32 and week 8 . The CPTS-RI is a scale comprised of 20 Likert-type items, intended for children from 6 to 16 years, which evaluates the symptoms of PTSD after exposure to various traumatic events. Each item frequency is rated on a 5-point scale, from never (=0) to almost always (=4). The global score consists of the sum of the 20 items and ranges from 0 to 80, with higher scores indicating higher PTSD symptom severity. The time required for completion of the scale is 15-20 min. A total score of 12-24 is associated with a mild level of PTSD, from 25-39 with a moderate level, from 40-59 with a severe level, and ≥60 with a very severe level.
Measured: week 32
Child Post-Traumatic Stress Reaction - Week 60 Index/CPTS-RI
The difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 60 and week 8. The CPTS-RI is a scale comprised of 20 Likert-type items, intended for children from 6 to 16 years, which evaluates the symptoms of PTSD after exposure to various traumatic events. Each item frequency is rated on a 5-point scale, from never (=0) to almost always (=4). The global score consists of the sum of the 20 items and ranges from 0 to 80, with higher scores indicating higher PTSD symptom severity. The time required for completion of the scale is 15-20 min. A total score of 12-24 is associated with a mild level of PTSD, from 25-39 with a moderate level, from 40-59 with a severe level, and ≥60 with a very severe level.
Measured: week 60
Child PTSD Checklist-Child version/CPC-C total score
The difference between the Child PTSD Checklist-Child version/CPC-C total score administered at week 8 and week 0 on items 14-34. The CPC-C includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-C 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 8
Child PTSD Checklist-Child version/CPC-C total score - Week 32
The difference between the Child PTSD Checklist-Child version/CPC-C total score administered at week 8 and week 32 on items 14-34. The CPC-C includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-C 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 32
Child PTSD Checklist-Child version/CPC-C total score - Week 60
The difference between the Child PTSD Checklist-Child version/CPC-C total score administered at week 8 and week 60 on items 14-34. The CPC-C includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-C 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 60
Child PTSD Checklist-Parent version/CPC-P total score - Week 32
The difference between the Child PTSD Checklist-Parent version/CPC-P total score administered at week 8 and week 32 on items 14-34 (PTSD symptom items). The CPC-P includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-P, 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 32
Child PTSD Checklist-Parent version/CPC-P total score - Week 60
The difference between the Child PTSD Checklist-Parent version/CPC-P total score administered at week 8 and week 60 on items 14-34 (PTSD symptom items). The CPC-P includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-P, 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 60
Child PTSD Checklist-Parent version/CPC-P total score
The difference between the Child PTSD Checklist-Parent version/CPC-P total score administered at week 8 and week 0 on items 14-34 (PTSD symptom items). The CPC-P includes a traumatic events page, 21 PTSD symptoms and 6 items of functional impairment. It is free in the public domain. For scoring the CPC-P, 7-18 years (Version May 23, 2014.), the Traumatic Events page (items 1-13) is important to include before administering the symptom portion. Items 14-34 are PTSD symptom items.
Measured: Week 8
Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5
The percentage of children without a current diagnosis of PTSD assessing with Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5. The K-SADS-PL-DSM5 (November 2016) is a semi-structured diagnostic interview designed to collect information from the child or adolescent as well as their parents or other informants.
Measured: week 8
Current diagnosis of PTSD at Week 32
The percentage of children without a current diagnosis of PTSD assessing with Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5. The K-SADS-PL-DSM5 (November 2016) is a semi-structured diagnostic interview designed to collect information from the child or adolescent as well as their parents or other informants.
Measured: week 32
Children Depression Inventory/CDI total score
The difference between the Children Depression Inventory/CDI total score administered at week 8 and week 0. The CDI is comprised of 27 items assessing self-reported symptoms of depression in children and adolescents 7-17 years of age.
Measured: week 8
Children Depression Inventory/CDI total score - Week 32
The difference between the Children Depression Inventory/CDI total score administered at week 8 and week 32. The CDI is comprised of 27 items assessing self-reported symptoms of depression in children and adolescents 7-17 years of age.
Measured: week 32
Children Depression Inventory/CDI total score - Week 60
The difference between the Children Depression Inventory/CDI total score administered at week 8 and week 60. The CDI is comprised of 27 items assessing self-reported symptoms of depression in children and adolescents 7-17 years of age.
Measured: week 60
Children's Sleep Habits Questionnaire/CSHQ Parent version total score
The difference between the Children's Sleep Habits Questionnaire/CSHQ Parent version total score administered at week 8 and week 0.The CSHQ was designed by clinical researchers at Brown University for children aged 4 through 12 years, to screen for the most common sleep problems in that age group.The first column 'of responses are scored: Usually=3, Sometimes=2, Rarely=1 for the entire questionnaire (except for the R=reversed items, which are considered to be "desirable" sleep behaviors, and thus scored in the opposite direction)
Measured: week 8
Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 32
The difference between the Children's Sleep Habits Questionnaire/CSHQ Parent version total score administered at week 8 and week 32.The CSHQ was designed by clinical researchers at Brown University for children aged 4 through 12 years, to screen for the most common sleep problems in that age group.The first column 'of responses are scored: Usually=3, Sometimes=2, Rarely=1 for the entire questionnaire (except for the R=reversed items, which are considered to be "desirable" sleep behaviors, and thus scored in the opposite direction)
Measured: week 32
Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 60
The difference between the Children's Sleep Habits Questionnaire/CSHQ Parent version total score administered at week 8 and week 60.The CSHQ was designed by clinical researchers at Brown University for children aged 4 through 12 years, to screen for the most common sleep problems in that age group.The first column 'of responses are scored: Usually=3, Sometimes=2, Rarely=1 for the entire questionnaire (except for the R=reversed items, which are considered to be "desirable" sleep behaviors, and thus scored in the opposite direction)
Measured: week 60
Comorbidity of other mental disorders
Using the K-SADS-PL DSM-5
Measured: week 8
Corsi Blocks task
The difference between the Corsi blocks task administered at week 0 and at week 8. The Corsi Blocks task assesses the visuospatial component of working memory but uses various cognitive processes. The subject needs to reproduce, in the same or reverse order, a sequence of pointing movements to different cubes shown by the rater
Measured: week 8
CGAS Children's Global Assessment Scale total score
The difference between the CGAS Children's Global Assessment Scale total score administered at week 8 and the score administered at week 32. The Childrens Global Assessment Scale (CGAS) is a measure developed by Schaffer and colleagues at the Department of Psychiatry, Columbia University to provide a global measure of level of functioning in children and adolescents. The measure provides a single global rating only, on scale of 0-100.
Measured: week 32
CGAS Children's Global Assessment Scale total score - Week 60
The difference between the CGAS Children's Global Assessment Scale total score administered at week 8 and the score administered at week 60. The Childrens Global Assessment Scale (CGAS) is a measure developed by Schaffer and colleagues at the Department of Psychiatry, Columbia University to provide a global measure of level of functioning in children and adolescents. The measure provides a single global rating only, on scale of 0-100.
Measured: week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Feb 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Birmes, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985344
- Sponsor's protocol ID
- RC31/18/0471
- Other IDs
- 2020-005956-39
- Acronym
- PPP
- Status last verified
- Aug 2023
- First submitted
- 21 Jul 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olliac B, Birmes P, Bui E, Allenou C, Brunet A, Claudet I, Sales de Gauzy J, Grandjean H, Raynaud JP. Validation of the French version of the Child Post-Traumatic Stress Reaction Index: psychometric properties in French speaking school-aged children. PLoS One. 2014 Dec 2;9(12):e112603. doi: 10.1371/journal.pone.0112603. eCollection 2014.
PubMed 25460912Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.
PubMed 33612830Birmes P, Raynaud JP, Daubisse L, Brunet A, Arbus C, Klein R, Cailhol L, Allenou C, Hazane F, Grandjean H, Schmitt L. Children's enduring PTSD symptoms are related to their family's adaptability and cohesion. Community Ment Health J. 2009 Aug;45(4):290-9. doi: 10.1007/s10597-008-9166-3. Epub 2009 Jul 21.
PubMed 19621258
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
- ClinicalTrials.gov ID
- NCT04985344
- Acronym / sponsor ID
- PPP / RC31/18/0471
- Conditions
- PTSD
- Keywords
- PTSD, traumatic memory reactivation, pediatric, Propranolol, Post-traumatic stress disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
Detailed description
By age 18, roughly 8% of traumatized youth have met criteria for a diagnosis of PTSD, with numbers rising up to 40% in cases of sexual abuse and assault. To date there is no empirical support for the use of psychopharmacological interventions as treatment of pediatric PTSD. Trauma-focused psychotherapeutic/TFP approaches should be favored in childhood PTSD. However, when compared to active control conditions, TFP produced a mean effect size on child and adolescents population (g=0.83). Moreover, in therapies with a substantial exposure component, the intense and lengthy reexperiencing of the traumatic event results in a substantial proportion of participants dropping out.
The reactivation of a previously consolidated memory can make it labile, subsequently requiring a re-stabilization of it called reconsolidation of the memory.
Acting on these reconsolidation processes makes possible to interfere with the subsequent storage of this memory.
The combination of the targeted reactivation of the traumatic memory and the intake of an agent that decreases the reconsolidation can thus disrupt the recall of unwanted memories and thus serve as a treatment for people suffering from traumatic memories, such as in PTSD.
Since stimulation of β-noradrenergic receptors facilitates the consolidation of memories as well as their re-consolidation, an antagonist of these receptors, propranolol, has generated considerable interest as a treatment to alleviate emotional and traumatic memories in individuals with PTSD.
In adults diagnosed with long-standing PTSD two 6-week, double-blind, placebocontrolled, randomised clinical trials, one in 60 subjects and the other in 67 have shown promising results. PTSD participants who actively recalled their traumatic event under the influence of propranolol once a week for up to 6 weeks showed a substantial decrease in symptom ratings compared with placebo. Thus, all of this data led the team to propose a comparable design study in children with PTSD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranolol Oral Product, Other: memory reactivationPatient will receive oral propranolol |
| Placebo | Placebo comparator | Drug: Placebo, Other: memory reactivationPatient will receive oral placebo |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 7-12 years
- CPTS-RI total score ≥40
- Primary diagnosis of PTSD (6 months or more after the traumatic event)
- Heart rate ≥ 55 bpm
- Systolic blood pressure ≥ 95 mm Hg
Key exclusion criteria (17 listed)
- Age<7 years or ≥13 years
- Children whose parents have been deprived of their authority
- Contraindication to propranolol (cardiogenic shock, sinus bradycardia, hypotension (< fifth percentile oscillometric or <2SD) (Banker et al., 2016 - see APPENDIX 1), greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
- Concurrent medication with possible interactions with propranolol (cf 8.2)
- Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD (Antidepressants, atypical antipsychotics, mood stabilizers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol Oral ProductAlso: PropranololChild will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance. | Drug | Propranolol |
| PlaceboChild will receive oral placebo (syrup). The dose of placebo will increase gradually over the first 3 treatment sessions in order to match propranolol intervention. | Drug | Placebo |
| memory reactivation90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma. | Other | Placebo, Propranolol |
Primary outcome
Child Post-Traumatic Stress Reaction Index/CPTS-RI
Time frame: week 8
The main evaluation criterion will be the difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 8 and week 0. The CPTS-RI is a scale comprised of 20 Likert-type items, intended for children from 6 to 16 years, which evaluates the symptoms of PTSD after exposure to various traumatic events. Each item frequency is rated on a 5-point scale, from never (=0) to almost always (=4). The global score consists of the sum of the 20 items and ranges from 0 to 80, with higher scores indicating higher PTSD symptom severity. The time required for completion of the scale is 15-20 min. A total score of 12-24 is associated with a mild level of PTSD, from 25-39 with a moderate level, from 40-59 with a severe level, and ≥60 with a very severe level.
20 secondary outcomes
Child Post-Traumatic Stress Reaction - Week 32 Index/CPTS-RI
Time frame: week 32
Child Post-Traumatic Stress Reaction - Week 60 Index/CPTS-RI
Time frame: week 60
Child PTSD Checklist-Child version/CPC-C total score
Time frame: Week 8
Child PTSD Checklist-Child version/CPC-C total score - Week 32
Time frame: Week 32
Child PTSD Checklist-Child version/CPC-C total score - Week 60
Time frame: Week 60
Child PTSD Checklist-Parent version/CPC-P total score - Week 32
Time frame: Week 32
Child PTSD Checklist-Parent version/CPC-P total score - Week 60
Time frame: Week 60
Child PTSD Checklist-Parent version/CPC-P total score
Time frame: Week 8
Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5
Time frame: week 8
Current diagnosis of PTSD at Week 32
Time frame: week 32
Children Depression Inventory/CDI total score
Time frame: week 8
Children Depression Inventory/CDI total score - Week 32
Time frame: week 32
Children Depression Inventory/CDI total score - Week 60
Time frame: week 60
Children's Sleep Habits Questionnaire/CSHQ Parent version total score
Time frame: week 8
Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 32
Time frame: week 32
Children's Sleep Habits Questionnaire/CSHQ Parent version total score - Week 60
Time frame: week 60
Comorbidity of other mental disorders
Time frame: week 8
Corsi Blocks task
Time frame: week 8
CGAS Children's Global Assessment Scale total score
Time frame: week 32
CGAS Children's Global Assessment Scale total score - Week 60
Time frame: week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Background: PubMed 25460912Olliac B, Birmes P, Bui E, Allenou C, Brunet A, Claudet I, Sales de Gauzy J, Grandjean H, Raynaud JP. Validation of the French version of the Child Post-Traumatic Stress Reaction Index: psychometric properties in French speaking school-aged children. PLoS One. 2014 Dec 2;9(12):e112603. doi: 10.1371/journal.pone.0112603. eCollection 2014.
- Background: PubMed 33612830Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.
- Background: PubMed 19621258Birmes P, Raynaud JP, Daubisse L, Brunet A, Arbus C, Klein R, Cailhol L, Allenou C, Hazane F, Grandjean H, Schmitt L. Children's enduring PTSD symptoms are related to their family's adaptability and cohesion. Community Ment Health J. 2009 Aug;45(4):290-9. doi: 10.1007/s10597-008-9166-3. Epub 2009 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Birmes, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propranolol Oral Product and memory reactivation in people with PTSD, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Birmes, PH (05 34 55 75 00 ext. +33, birmes.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Post-Traumatic Stress Reaction Index/CPTS-RI (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985344, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.