Treating pediatric PTSD with memory reactivation and propranolol
Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
This study is testing if giving children with PTSD a medication called propranolol along with special memory exercises can help lessen the emotional pain from their traumatic memories.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04985344 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of propranolol, a beta-blocker, in conjunction with memory reactivation techniques to treat pediatric post-traumatic stress disorder (PTSD) in children aged 7-12. The study aims to disrupt the reconsolidation of traumatic memories, potentially reducing the emotional impact of these memories. Participants will receive either propranolol or a placebo while undergoing memory reactivation sessions. The trial seeks to provide a novel approach to treating PTSD in children, where traditional therapies may lead to high dropout rates due to the intensity of re-experiencing trauma.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7-12 years who have been diagnosed with PTSD for at least six months.
Not a fit: Patients younger than 7 or older than 12 years, or those with contraindications to propranolol, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new, effective treatment option for children suffering from PTSD.
How similar studies have performed: While traditional trauma-focused therapies have shown some success, the use of propranolol in this context is a novel approach that has not been extensively tested in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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) * 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Toulouse
- Toulouse University Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Philippe Birmes, PH — University Hospital, Toulouse
- Study coordinator: Philippe Birmes, PH
- Email: birmes.p@chu-toulouse.fr
- Phone: 05 34 55 75 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.