Posttraumatic Stress DisorderPhase 2NCT01349439
Reducing Reconsolidation of Trauma Memories With Propranolol
A Phase 2 study testing Propranolol and Short acting + long acting propranolol + memory reactivation in people with Posttraumatic Stress Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Propranolol and Short acting + long acting propranolol + memory reactivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Jan 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffer from chronic PTSD for at least 6 consecutive months;
- Obtain a score of 33 or more on the Impact of Events Scale-Revised:
- For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
- Accept to not commence taking new medications on a regular basis during the study.
Who cannot join
- Hypotension;
- Cardiac rhythm below 55 beats per minute;
- Medical conditions that contraindicates the administration of propranolol;
- Previous adverse reaction to, or non-compliance with, beta-blockers;
- Current use of medication that may involve potentially dangerous interactions with propranolol;
- Any medication that can have an impact on cardiac rhythm;
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- Women who are breast feeding;
- Past or present bipolar disorder or psychosis,
- Present substance abuse or dependence, suicidal ideation;
- Participating in psychotherapy other than support psychotherapy;
- An average score above 20 on the Dissociative Experience Scale.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Douglas Mental Health University Institute
Verdun, Quebec, H4H 1R3
Andrea Ashbaugh, Ph.D., 514-761-6131 ext. 4341, andrea.ashbaugh@douglas.mcgill.ca
Alain Brunet, Ph.D.
About this study
Official title: Reduction of the Reconsolidation of the Trauma Memory With Propranolol
The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Propranolol, Short acting + long acting propranolol + memory reactivation
- 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
1mg per Kg (participant weight)
Short acting + long acting propranolol + memory reactivationDrug
After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol + Memory Reactivation | Experimental | This arm involves recalling the traumatic event after administration of propranolol Receives: Drug: Propranolol |
| Placebo + Memory reactivation | Experimental | This arm involves recalling the traumatic event after administration of a placebo Receives: Drug: Propranolol |
| Placebo + No Memory Reactivation | Experimental | This arm involves administration of a placebo without recalling the traumatic event Receives: Drug: Propranolol |
| Propranolol + No Memory Reactivation | Experimental | This arm involves administration of propranolol without recalling the traumatic event Receives: Drug: Propranolol |
| Open-label Propranolol + Memory Reactivation | Other | All participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks. Receives: Drug: Short acting + long acting propranolol + memory reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyogram
Measured: Two weeks post-treatment
Heart rate
Measured: Two weeks post-treatment
Skin conductance
Measured: Two weeks post-treatment
Secondary outcomes (4)
PTSD symptom levels
PTSD symptom levels will be assessed 2 to 26 weeks after randomization
Measured: 2 to 26 weeks
Quality of life
Quality of life assessments will be conducted 2 to 26 weeks following randomization
Measured: 2 to 26 weeks
Memory Experience
The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization
Measured: 2 to 26 weeks
Psychophysiological assessments
Psychophysiological assessments will be repeated 26 weeks following randomization
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Alain Brunet, Ph.D., Douglas Mental Health University Institute
- Investigators
- Alain Brunet, Ph.D., Principal investigator, Douglas Institute Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349439
- Sponsor's protocol ID
- 08-44
- Status last verified
- Jun 2014
- First submitted
- 31 Mar 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.
PubMed 17588604
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of the Reconsolidation of the Trauma Memory With Propranolol
- ClinicalTrials.gov ID
- NCT01349439
- Acronym / sponsor ID
- 08-44
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2011
- Primary completion
- Jan 2015 (estimated)
- First posted
- 6 May 2011 (estimated)
- 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 purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Propranolol + Memory Reactivation | Experimental | Drug: PropranololThis arm involves recalling the traumatic event after administration of propranolol |
| Placebo + Memory reactivation | Experimental | Drug: PropranololThis arm involves recalling the traumatic event after administration of a placebo |
| Placebo + No Memory Reactivation | Experimental | Drug: PropranololThis arm involves administration of a placebo without recalling the traumatic event |
| Propranolol + No Memory Reactivation | Experimental | Drug: PropranololThis arm involves administration of propranolol without recalling the traumatic event |
| Open-label Propranolol + Memory Reactivation | Other | Drug: Short acting + long acting propranolol + memory reactivationAll participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffer from chronic PTSD for at least 6 consecutive months;
- Obtain a score of 33 or more on the Impact of Events Scale-Revised:
- For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
- Accept to not commence taking new medications on a regular basis during the study.
Key exclusion criteria (11 listed)
- Hypotension;
- Cardiac rhythm below 55 beats per minute;
- Medical conditions that contraindicates the administration of propranolol;
- Previous adverse reaction to, or non-compliance with, beta-blockers;
- Current use of medication that may involve potentially dangerous interactions with propranolol;
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 |
|---|---|---|
| Propranolol1mg per Kg (participant weight) | Drug | Placebo + Memory reactivation, Placebo + No Memory Reactivation, Propranolol + Memory Reactivation, Propranolol + No Memory Reactivation |
| Short acting + long acting propranolol + memory reactivationAfter completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants. | Drug | Open-label Propranolol + Memory Reactivation |
Primary outcome
Electromyogram
Time frame: Two weeks post-treatment
Heart rate
Time frame: Two weeks post-treatment
Skin conductance
Time frame: Two weeks post-treatment
4 secondary outcomes
PTSD symptom levels
Time frame: 2 to 26 weeks
Quality of life
Time frame: 2 to 26 weeks
Memory Experience
Time frame: 2 to 26 weeks
Psychophysiological assessments
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Background: PubMed 17588604Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.
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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.
Alain Brunet, Ph.D. principal investigator
Douglas Institute Research Centre
1 site 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 and Short acting + long acting propranolol + memory reactivation in people with Posttraumatic Stress Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain R Brunet, Ph.D. (514-761-6131 ext. 4348, alain.brunet@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyogram (time frame: Two weeks post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349439, which also lists 1 linked publication.
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 24 Jun 2014.