Propranolol Treatment of Traumatic Memories (PTTM)

Posttraumatic Stress Disorder Clinical Trial

— PTTM  

Official title:

Propranolol Treatment of Traumatic Memories (PTTM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01069159
• Other study ID #: 505-2010
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2010
• Last updated: June 19, 2011
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2011
• Source: Mela, Mansfield, M.D.
• Contact: Robin Menzies, MBBS FRCPsych (UK) FRCP (C)
• Phone: 306-668-0505
• Email: knox[@]sasktel.net
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study will compare the responses of subjects with traumatic memories of varying vintages to either propranolol or placebo in a double-blind setting. It is hypothesized that those subjects who receive propranolol will experience less emotional distress when the memory is subsequently reactivated and less spontaneous re-experiences.

Description:

Traumatic memories are responsible for significant emotional distress and disability. They are a cardinal feature of Posttraumatic Stress Disorder (PTSD). Re-experiencing the original traumatic event in a number of different ways (e.g. nightmares, intrusive recollections and dissociative flashbacks) is accompanied by distressing symptoms. The reconsolidation theory of memory proposes that when long-term memories are reactivated, they remain labile for several hours before conversion back to long-term memory. During this period they are susceptible to amnestic agents, like propranolol.

Propranolol Hydrochloride will be compared to placebo in subjects who have emotional distress associated with re-experiences of traumatic events, whether in the context of PTSD or not. Two doses of propranolol or two doses of placebo will be given at the first visit.

The objective of the trial is to determine the effectiveness of brief treatment with propranolol on subjects with traumatic memories and associated symptoms. The research hypothesis is that propranolol will be more effective than placebo, as determined by the measures used, and that this positive outcome will support the reconsolidation theory of memory.

The subjects will undergo clinician rated assessments/scales to determine the presence of pre-treatment mental disorders. Subjects will complete self-rating measures/scales to determine the impact of the traumatic experience. Blood pressure and pulse rates will also be recorded.

Post-treatment outcomes using the same instruments to determine changes at four weeks will be recorded. The differences will be compared and subjected to statistical analysis.

There is an optional component of the study for subjects allocated to the placebo group. At the end of the study, these subjects will be given the opportunity of taking two doses of propranolol and attending a single follow-up session four weeks later for a further interview, rating scale and questionnaire completion. This will provide the subjects who were on placebo an opportunity of possibly benefiting from the active treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female adults between 18 and 70 years of age

• A traumatic memory, as an isolated symptom or in the context of Post-traumatic Stress Disorder

Exclusion Criteria:

• Pregnancy

• Breastfeeding

• Current treatment with either a beta-blocker or a corticosteroid medicine

• Medical contraindications, as outlined in the Compendium of Pharmaceutical and Specialties and the Product Monograph

• Subjects who want to retain every aspect of their memory for the traumatic event, as some memory could be lost

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Memory

Intervention

Drug:
• Propranolol Hydrochloride
The protocol of the study requires that two doses of propranolol (regular propranolol 40 mg followed two hours later by long-acting propranolol 60 mg) or placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Subjects will be randomized in a 1:1 ratio to either Propranolol treatment or placebo.
• Placebo
The protocol of the study requires that two doses of placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive placebo.

Locations

Country	Name	City	State
Canada	Knox Manse	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Mela, Mansfield, M.D.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Epub 2007 Jun 22. — View Citation

Nader K, Schafe GE, Le Doux JE. Fear memories require protein synthesis in the amygdala for reconsolidation after retrieval. Nature. 2000 Aug 17;406(6797):722-6. — View Citation

Pitman RK, Sanders KM, Zusman RM, Healy AR, Cheema F, Lasko NB, Cahill L, Orr SP. Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biol Psychiatry. 2002 Jan 15;51(2):189-92. — View Citation

Pitman RK. Post-traumatic stress disorder, hormones, and memory. Biol Psychiatry. 1989 Jul;26(3):221-3. Review. — View Citation

Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. Erratum in: Biol Psychiatry. 2003 Dec 15;54(12):1471. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be changes between the pretreatment and posttreatment scores in the Clinician Assessment Posttraumatic Scale (CAPS), Impact of Event Scale (IES) and Traumatic Memory Description Measure (TMDM) instruments.		Visit 2 (Week 4)	No
Secondary	The secondary endpoint will be changes between the treatment and posttreatment score in the other scales used - MINI, ZAS, ZDS and NIHS.		Visit 2 (Week 4)	No

External Links

•   More information on the PTTM study