Post Traumatic Stress DisorderPhase 2PROPRADONCT04921982
Efficacy of Traumatic Memory Modification Using Memory Reconsolidation and Propranolol Among Adolescents With PTSD
A Phase 2 study testing Propranolol in people with Post Traumatic Stress Disorder, run by Rennes University Hospital at 10 sites in France.
Trial summary
The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesFrance
- Study dates
- Oct 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Adolescents aged 12 to 18 years;
- Exposed to a single traumatic event or to events circumscribed in time, including sexual abuse in the absence of reminders in the environment;
- Fluent in French;
- Positive diagnosis of PTSD with the SCID-5;
- Disorders evolving for at least three months;
- Heart rate ≥ 55 bpm;
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- Systolic blood pressure ≥ 100 mmHg;
- Written parental or legal guardian consent;
- Written agreement by the adolescent;
- Adolescents affiliated, via their parents, to the French social security body.
Who cannot join
- - Medical condition contraindicating administration of propranolol (COPD, asthma, cardio-vascular insufficiency, heart failure as second- and third-degree atrioventricular blocks, Prinzmetal angor, pheochromocytoma, Raynaud disease, history of an anaphylactic reaction, sinus node disease, hypoglycemia, AV blocks)
- Known chronic renal or hepatic insufficiency
- Schizophrenia;
- Mental retardation;
- Autism spectrum disorder;
- Acute severe suicidal ideation
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- Traumatic brain injury (loss of consciousness > 10 minutes);
- Currently treated for substance or alcohol dependence;
- Currently treated for Attention Deficit Hyperactivity Disorder;
- Currently treated with a drug that can interfere with propranolol and that can represent a danger according to medical advice if it's suspended more than 24 hours.
- Currently treated with a bradycardic drug;
- Concurrent psychotropic medication with the exception of cyamemazine (suspended 48 hours before session)
- Concurrent trauma-focused psychotherapy in progress or stopped less than 1 month ago;
- Pregnancy or breast feeding.
- Current use of "recreative" toxic drugs
- Concurrent participation to another interventional study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Angers
Angers
CHU Besançon
Besançon
CH Bohars
Bohars
AP-HP Louis Mourier
Colombes
CH Le Havre
Le Havre
CHU Limoges
Limoges
CHU Nantes
Nantes
CHU Poitiers
Poitiers
CH Guillaume Régnier
Rennes, 35000
CHU Rouen
Rouen
About this study
Official title: The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder
The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Propranolol, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Oral administration of Propranolol, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse once a week for six consecutive weeks.
PlaceboDrug
Oral administration of Placebo, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse, once a week for six consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Not described Receives: Drug: Propranolol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on score of PCL-5
Difference on score on the PTSD Checklist for DSM-5 (PCL-5) between inclusion and one week after the end of treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017)
Measured: 7 weeks
Secondary outcomes (11)
Change on score of PCL-5 after each treatment session
Difference on score on the post-traumatic stress disorder Checklist for DSM-5 (PCL-5) between inclusion and after each dispensation of treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017) Scores consist of a total symptom severity score (from 0 to 80)
Consistent with the likert scale:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely Higher scores mean a worse outcome.
Measured: 6 weeks
Change on score of PCL-5 at 3 months
Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 3 months after the beginning of the treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017) Scores consist of a total symptom severity score (from 0 to 80)
Consistent with the likert scale:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely
Higher scores mean a worse outcome.
Measured: 3 months
Change on score of PCL-5 at 6 months
Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 6 months after the beginning of the treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017) Scores consist of a total symptom severity score (from 0 to 80)
Consistent with the likert scale:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely
Higher scores mean a worse outcome.
Measured: 6 months
Change on score of PCL-5 at 12 months
Difference on score on the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) between inclusion and 12 months after the beginning of the treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017) Scores consist of a total symptom severity score (from 0 to 80)
Consistent with the likert scale:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely Higher scores mean a worse outcome.
Measured: 12 months
Change in CPC-DSM5 questionnaire score
Difference in functional impairment score of CPC-DSM5 at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6 and 12 months after the beginning of treatment. Functional impairment score will be assessed using CHILD PTSD CHECKLIST PARENT questionnaire. CPC is a self-questionnaire of 12 items. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items. The CPSS-5-I also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items 15-20).
The interviewer rates the seven impairment items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28. The total impairment score does not contribute to the overall severity score.
Measured: 12 months
Change in SCID-5 questionnaire score
Difference in Categorical diagnosis of PTSD using SCID-5 questionnaire at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6 and 12 months after the beginning of treatment. SCID-5 is for Structured Clinical Interview for DSM-5 is a semi-structured interview guide for making the major DSM-5 diagnoses used for the diagnosis of PTSD and depression.
Measured: 12 months
Change in Child Depression Inventory score
Difference in Child Depression Inventory (CDI) score between inclusion visit and one week after the end of treatment, 6 months and 12 months after the beginning of treatment. There are 27 items quantifying symptoms such as depressed mood, hedonic capacity, vegetative functions, self-evaluation, and interpersonal behaviors. Each item consists of three statements graded in order of increasing severity from 0 to 2; children and adolescents select the one that characterized their symptoms best during the past 2 weeks. The item scores are combined into a total depression score, which ranges from 0 to 54. A higher CDI score means a higher depressive state.
Measured: 12 months
Change in Adolescent Dissociative Experience scale
Difference in Adolescent Dissociative Experience (DES-A) score at inclusion visit, one week after the end of treatment, 6 and 12 months after the beginning of treatment. DES-A is a 28-items selfquestionnaire. Each item reaches to 0 (never happening) to 10 (always happening)
Measured: 12 months
Change in Youth Self Report score
Scores for Behavioral and Somatic Disorders and for School/social functioning using Youth Self report (CBCL/YSR, parents/children) at inclusion visit , one week after the end of treatment, 6 and 12 months after the beginning of treatment. The YSR is a 112-item self-report designed for children and adolescents (ages 11-17) and largely used worldwide. It assesses behavioral competency and behavioral problems and parallels the Child Behavior Checklist (CBCL). The questionnaire provides scores for the following syndrome scales: anxious/depressed, withdrawn/depressed, somatic complains, social problems, thought problems, rule-breaking behavior, and aggressive behavior. The questionnaire provides scores for DSM-oriented scales.
The YSR consists of 112 questions, scored on a three-point Likert scale (0=absent,
1= occurs sometimes, 2=occurs often) Higher scores mean a worse outcome.
Measured: 12 months
Change in suicidal riskk using Mini-Kid questionnaire
Difference in acute suicidal risk using Mini Kid questionnaire at inclusion visit , one week after the end of treatment, 6 and 12 months after the beginning of treatment. The Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) is a short, structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders in children and adolescents. Only part C will be used to assess diagnosis of acute suicidal risk. Scores reaches from 0 to 10 Higher scores mean a worse outcome.
Measured: 12 months
Evaluation of the tolerance to treatment
Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks) by the research nurse: Clinical evaluation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: The study could not begin within the period of validity of the authorizations. The project has been abandoned in its initially authorized form. The final study report will not be produced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Dayan, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921982
- Sponsor's protocol ID
- 35RC18_8852_PROPRADO
- Acronym
- PROPRADO
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04921982
- Acronym / sponsor ID
- PROPRADO / 35RC18_8852_PROPRADO
- Conditions
- Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study could not begin within the period of validity of the authorizations. The project has been abandoned in its initially authorized form. The final study report will not be produced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranolol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- - Adolescents aged 12 to 18 years;
- Exposed to a single traumatic event or to events circumscribed in time, including sexual abuse in the absence of reminders in the environment;
- Fluent in French;
- Positive diagnosis of PTSD with the SCID-5;
- Disorders evolving for at least three months;
Key exclusion criteria (16 listed)
- - Medical condition contraindicating administration of propranolol (COPD, asthma, cardio-vascular insufficiency, heart failure as second- and third-degree atrioventricular blocks, Prinzmetal angor, pheochromocytoma, Raynaud disease, history of an anaphylactic reaction, sinus node disease, hypoglycemia, AV blocks)
- Known chronic renal or hepatic insufficiency
- Schizophrenia;
- Mental retardation;
- Autism spectrum disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololOral administration of Propranolol, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse once a week for six consecutive weeks. | Drug | Propranolol |
| PlaceboOral administration of Placebo, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse, once a week for six consecutive weeks. | Drug | Placebo |
Primary outcome
Change on score of PCL-5
Time frame: 7 weeks
Difference on score on the PTSD Checklist for DSM-5 (PCL-5) between inclusion and one week after the end of treatment. PCL-5 is a 20-item self-report measure of the DSM-5 symptoms of PTSD used as a continuous measure. A decrease of 10 points on the PCL is usually considered as a clinically significant improvement. It has been used worldwide and among adolescents (Wang, 2015; Cao, 2017)
11 secondary outcomes
Change on score of PCL-5 after each treatment session
Time frame: 6 weeks
Change on score of PCL-5 at 3 months
Time frame: 3 months
Change on score of PCL-5 at 6 months
Time frame: 6 months
Change on score of PCL-5 at 12 months
Time frame: 12 months
Change in CPC-DSM5 questionnaire score
Time frame: 12 months
Change in SCID-5 questionnaire score
Time frame: 12 months
Change in Child Depression Inventory score
Time frame: 12 months
Change in Adolescent Dissociative Experience scale
Time frame: 12 months
Change in Youth Self Report score
Time frame: 12 months
Change in suicidal riskk using Mini-Kid questionnaire
Time frame: 12 months
Evaluation of the tolerance to treatment
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Dayan, Pr principal investigator
Rennes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Post Traumatic Stress Disorder, run by Rennes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on score of PCL-5 (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.