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New treatment option for PTSD
Official title Treatment of Pediatric Post-traumatic Stress Disorder With Memory Reactivation Under the Influence of Propranolol
ClinicalTrials.gov ID: NCT04985344
What this study is testing
What is Propranolol Oral Product?
Propranolol Oral Product is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for ptsd.
Also referred to as Propranolol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 12
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Concurrent psychotherapy (\>1 structured session/month declared by the clinician who follows the child)
See the full eligibility 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
- 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...
- 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 treatment study
- Renal or Hepatic Impairment
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.