At a glance
ClinicalIndex Comparison Record- ✓Children aged 7-12 years
- ✓CPTS-RI total score ≥40
- ✓Primary diagnosis of PTSD, 6 months or more after traumatic event
- ✓Heart rate ≥55 bpm
- ✕Age <7 years or ≥13 years
- ✕Parents deprived of parental authority
- ✕Contraindications to propranolol including cardiogenic shock, sinus bradycardia, hypotension, heart block, heart failure, bronchial asthma, hypersensitivity
- ✕Concurrent medications with interactions with propranolol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol: A Randomized Placebo-controlled Trial. PPP
In Brief
A Phase 3 clinical trial evaluating Propranolol Oral Product, Placebo, and 1 other intervention for PTSD. Currently recruiting, targeting 92 participants across 1 site.
Detailed 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. 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.
Study Details
Timeline
Interventions
Child will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance.
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.
90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma.