Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol
Recruiting
Phase 3
Interventional Study
PTSD
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 7 – 12
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 92 (estimated)
- Sponsor
- University Hospital, Toulouse · Other
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About This Trial
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…
Trial Locations
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Eligibility 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 p…
Contacts