EUCTR2020-005956-39-FR
Active, Not Recruiting
Phase 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 enrollmentJanuary 22, 2021
ConditionsPost-traumatic Stress DisorderMedDRA version: 20.0Level: HLTClassification code 10042211Term: Stress disordersSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsPropanolol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- CHU Toulouse
- Enrollment
- 92
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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)
- •\-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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 3
Treatment of posttramaumatic stress disorders in patients in in-patient addiction rehabilitation with the EMDR-method - a randomized controlled trialF43.1Post-traumatic stress disorderDRKS00009007Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V. (GfR)158
Recruiting
Phase 3
Effect of Homoeopathy and CPT (Cognitive Processing Therapy) in Post Traumatic Stress DisorderCTRI/2022/05/042841Central Council for Research in Homoeopathy
Not Yet Recruiting
N/A
Treatment of PTSD and AddictioNL-OMON27175Arkin, Department of Research, Amsterdam, the Netherlands; University of Amsterdam, the Netherlands.205
Not Yet Recruiting
Phase 4
A Clinical Study On Post Covid Stress Disorder And Its Homoeopathic ManagementHealth Condition 1: F431- Post-traumatic stress disorder (PTSD)CTRI/2022/04/041620S VIKRAM
Completed
N/A
Posttraumatic Stress Disorder and Posttraumatic Stress Symptoms in Parents Two Years after the Diagnosis of Expecting a Child with Major Congenital Anatomical Anomalies: a prospective design regarding prevalence, course and determinantsNL-OMON30791Erasmus MC, Universitair Medisch Centrum Rotterdam150