Phase 3 PTSD Trial, Recruiting (NCT04985344)

Phase 3 PTSD Trial, Recruiting NCT04985344 Sponsor: University Hospital, Toulouse Condition: PTSD

Printed from Voxsanity (voxsanity.com.au) — NCT04985344 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Children aged 7 to 12 years old
Children who score 40 or above on a specific PTSD symptom questionnaire called the CPTS-RI
Children whose main diagnosis is PTSD, where the traumatic event happened at least 6 months ago
Children with a resting heart rate of 55 beats per minute or higher
Children with a systolic (top number) blood pressure of 95 mmHg or higher
Children who are covered by a social security (health insurance) scheme
Children whose parents or legal guardians have signed a written consent form, along with the investigator
Children who have agreed to take part in the study, and where both the child and their parents or legal guardians can speak and read French fluently

Who may not be able to join:

Children younger than 7 years old or aged 13 years or older
Children whose parents have had their parental rights legally removed
Children who have a medical reason they cannot take propranolol, such as certain heart conditions, low blood pressure, asthma, or a known allergy or sensitivity to propranolol (confirm with trial site)
Children currently taking other medications that may interact with propranolol (confirm with trial site)
Children currently taking psychiatric medications that have been shown to help with PTSD symptoms, such as antidepressants, certain antipsychotics, or mood stabilisers
Children currently receiving structured psychological therapy more than once a month, as reported by their treating clinician
Children currently experiencing active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, ADHD, or autism spectrum disorder
Children who have psoriasis (a skin condition)
Children who are prone to low blood sugar (hypoglycaemia)
Children diagnosed with obsessive-compulsive disorder
Children diagnosed with bipolar disorder
Children with an intellectual disability
Children who have had a traumatic brain injury involving loss of consciousness lasting more than 10 minutes
Children currently being treated with medication that slows the heart rate
Children already taking part in another interventional clinical study
Children with significant kidney or liver problems
Children who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 27 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Philippe Birmes, PH, University Hospital, Toulouse

Phone: 05 34 55 75 00

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT04985344

Sponsor: University Hospital, Toulouse

Phase: Phase 3

Status: Recruiting

Condition: PTSD

Trial contact: 05 34 55 75 00

More information: https://clinicaltrials.gov/study/NCT04985344

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children aged 7 to 12 years old
Children who score 40 or above on a specific PTSD symptom questionnaire called the CPTS-RI
Children whose main diagnosis is PTSD, where the traumatic event happened at least 6 months ago
Children with a resting heart rate of 55 beats per minute or higher
Children with a systolic (top number) blood pressure of 95 mmHg or higher
Children who are covered by a social security (health insurance) scheme
Children whose parents or legal guardians have signed a written consent form, along with the investigator
Children who have agreed to take part in the study, and where both the child and their parents or legal guardians can speak and read French fluently

Who may not be able to join:

Children younger than 7 years old or aged 13 years or older
Children whose parents have had their parental rights legally removed
Children who have a medical reason they cannot take propranolol, such as certain heart conditions, low blood pressure, asthma, or a known allergy or sensitivity to propranolol (confirm with trial site)
Children currently taking other medications that may interact with propranolol (confirm with trial site)
Children currently taking psychiatric medications that have been shown to help with PTSD symptoms, such as antidepressants, certain antipsychotics, or mood stabilisers
Children currently receiving structured psychological therapy more than once a month, as reported by their treating clinician
Children currently experiencing active psychosis, anorexia nervosa, bulimia nervosa, binge-eating disorder, ADHD, or autism spectrum disorder
Children who have psoriasis (a skin condition)
Children who are prone to low blood sugar (hypoglycaemia)
Children diagnosed with obsessive-compulsive disorder
Children diagnosed with bipolar disorder
Children with an intellectual disability
Children who have had a traumatic brain injury involving loss of consciousness lasting more than 10 minutes
Children currently being treated with medication that slows the heart rate
Children already taking part in another interventional clinical study
Children with significant kidney or liver problems
Children who are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

University Hospital, Toulouse

Registry

ClinicalTrials.gov

Start date

1 February 2023

Est. completion

1 September 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Child Post-Traumatic Stress Reaction Index/CPTS-RI

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov