Treatment of pediatric Post-traumatic Stress Disorder with memory reactivation under the influence of propranolol: A randomized placebo-controlled trial

Treatment of pediatric Post-traumatic Stress Disorder with memory reactivation under the influence of propranolol: A randomized placebo-controlled trial - PPP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005956-39-FR

Enrollment

Registered

2021-01-22

Start date

2021-04-06

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder MedDRA version: 20.0 Level: HLT Classification code 10042211 Term: Stress disorders System Organ Class: 100000004873

Interventions

Trade Name: Propanolol Product Name: Propanolol Pharmaceutical Form: Syrup Pharmaceutical form of the placebo: Syrup Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Children aged 7-12 years -CPTS-RI total score =40 -Primary diagnosis of PTSD (6 months or more after the traumatic event) -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 Are the trial subjects under 18? yes Number of subjects for this age range: 92 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Age1 stuctured session/month declared by the clinician who follows the child) -Current active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, attention-deficit hyperactivity disorder, autism spectrum disorder -Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the efficacy of oral propranolol (0.66 mg/Kg to 1 mg/Kg vs. placebo) administered 90’ prior to six weekly sessions of traumatic memory reactivation in reducing self-reported PTSD symptom severity in children (aged 7-12) with long lasting PTSD (=6 months) at endpoint (1-week post-treatment=1 week after the 6th and last treatment session);Secondary Objective: -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing parent-reported PTSD symptom severity in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing rates of PTSD in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing self-reported major depressive episode symptom severity in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation on all outcomes at 6- month follow-up -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation on all outcomes at 1-year follow-up ;Primary end point(s): The main evaluation criterion will be the difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 0 before the first treatment session and the CPTS-RI total score administered at week 8 (study endpoint=one week after the sixth and last treatment session).;Timepoint(s) of evaluation of this end point: week 8	—

Measure

Time frame

Main Objective: To examine the efficacy of oral propranolol (0.66 mg/Kg to 1 mg/Kg vs. placebo) administered 90’ prior to six weekly sessions of traumatic memory reactivation in reducing self-reported PTSD symptom severity in children (aged 7-12) with long lasting PTSD (=6 months) at endpoint (1-week post-treatment=1 week after the 6th and last treatment session);Secondary Objective: -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing parent-reported PTSD symptom severity in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing rates of PTSD in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation in reducing self-reported major depressive episode symptom severity in children with PTSD aged 7-12 at endpoint -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation on all outcomes at 6- month follow-up -To examine the efficacy of propranolol (vs. placebo) administered prior to six weekly sessions of traumatic memory reactivation on all outcomes at 1-year follow-up ;Primary end point(s): The main evaluation criterion will be the difference between the Child Post-Traumatic Stress Reaction Index/CPTS-RI total score administered at week 0 before the first treatment session and the CPTS-RI total score administered at week 8 (study endpoint=one week after the sixth and last treatment session).;Timepoint(s) of evaluation of this end point: week 8

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Secondary

Measure	Time frame
Secondary end point(s): The difference between the Child PTSD Checklist-Child version/CPC-C total score on items 14-34 (PTSD symptom items) administered at week 0 before the first treatment session and the CPC-C total score on items 14-34 administered at week 8 (study endpoint). The difference between the Child PTSD Checklist-Parent version/CPC-P total score on items 14-34 (PTSD symptom items) administered at week 0 before the first treatment session and the CPC-P total score on items 14-34 administered at week 8 (study endpoint). The percentage of children without a current diagnosis of PTSD at week 8 (study endpoint) one week after the sixth and last treatment session. A current diagnosis of PTSD will be assessed by the semi-structured diagnosis interview Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5 at study endpoint. The difference between the Children Depression Inventory/CDI total score administered at week 0 before the first treatment session and the CDI total score at week 8 (study endpoint) one week after the sixth and last treatment session. The difference between the Children’s Sleep Habits Questionnaire/CSHQ Parent version total score administered at week 0 before the first treatment session and the CSHQ total score at week 8 (study endpoint) one week after the sixth and last treatment session. The difference between the CPTS-RI total score administered at week 8 and the CPTS-RI total score administered at week 32 (6 months after the sixth and last treatment session), and at week 60 (1 year after the sixth and last treatment session). The difference between the CPC-C total score on items 14-34 (PTSD symptom items) administered at week 8 and the CPC-C total score on items 14-34 administered at week 32 (6 months after the sixth and last treatment session), and at week 60 (1 year after the sixth and last treatment session). The difference between the CPC-P total score on items 14-34 (PTSD symptom items) administered at week 8 and the	—

Measure

Time frame

Secondary end point(s): The difference between the Child PTSD Checklist-Child version/CPC-C total score on items 14-34 (PTSD symptom items) administered at week 0 before the first treatment session and the CPC-C total score on items 14-34 administered at week 8 (study endpoint). The difference between the Child PTSD Checklist-Parent version/CPC-P total score on items 14-34 (PTSD symptom items) administered at week 0 before the first treatment session and the CPC-P total score on items 14-34 administered at week 8 (study endpoint). The percentage of children without a current diagnosis of PTSD at week 8 (study endpoint) one week after the sixth and last treatment session. A current diagnosis of PTSD will be assessed by the semi-structured diagnosis interview Kiddie-SADS-Present and Lifetime Version DSM-5/K-SADS-PL-DSM5 at study endpoint. The difference between the Children Depression Inventory/CDI total score administered at week 0 before the first treatment session and the CDI total score at week 8 (study endpoint) one week after the sixth and last treatment session. The difference between the Children’s Sleep Habits Questionnaire/CSHQ Parent version total score administered at week 0 before the first treatment session and the CSHQ total score at week 8 (study endpoint) one week after the sixth and last treatment session. The difference between the CPTS-RI total score administered at week 8 and the CPTS-RI total score administered at week 32 (6 months after the sixth and last treatment session), and at week 60 (1 year after the sixth and last treatment session). The difference between the CPC-C total score on items 14-34 (PTSD symptom items) administered at week 8 and the CPC-C total score on items 14-34 administered at week 32 (6 months after the sixth and last treatment session), and at week 60 (1 year after the sixth and last treatment session). The difference between the CPC-P total score on items 14-34 (PTSD symptom items) administered at week 8 and the

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Countries

France

Contacts

Public ContactAmandine PAUZE

CHU Toulouse

pauze.a@chu-toulouse.fr05-61-77-84-34+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026