EUCTR2020-005956-39-FRActive, not recruitingPhase 1
Treatment of pediatric Post-traumatic Stress Disorder with memory reactivation under the influence of propranolol: A randomized placebo-controlled trial - PPP
CHU Toulouse0 sites92 target enrollmentStarted: January 22, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •-Age<7 years or =13 years
- •-Child or parents that don’t have a good understanding of the French language according to investigator's opinion
- •- 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)., greater than first-degree heart block, heart failure, bronchial asthma and hypersensitivity to propranolol hydrochloride)
- •-Heart Rate/HR<50 bpm
- •-Concurrent medication with possible interactions with propranolol
- •--Concurrent psychotropic drugs that have been shown to be effective in improving symptoms of PTSD
- •-Concurrent psychotherapy (>1 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
Investigators
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