Propranolol Treatment of Traumatic Memories (PTTM)
Information source: Mela, Mansfield, M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Memory; Posttraumatic Stress Disorder
Intervention: Propranolol Hydrochloride (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mela, Mansfield, M.D. Official(s) and/or principal investigator(s): Robin Menzies, MBBS FRCPsych (UK) FRCP (C), Principal Investigator
Overall contact: Robin Menzies, MBBS FRCPsych (UK) FRCP (C), Phone: 306-668-0505, Email: knox@sasktel.net
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.
Clinical Details
Official title: Propranolol Treatment of Traumatic Memories (PTTM)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The secondary endpoint will be changes between the treatment and posttreatment score in the other scales used - MINI, ZAS, ZDS and NIHS.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Robin Menzies, MBBS FRCPsych (UK) FRCP (C), Phone: 306-668-0505, Email: knox@sasktel.net
Knox Manse, Saskatoon, Saskatchewan S7N 2M5, Canada; Recruiting Robin Menzies, MBBS FRCPsych (UK) FRCP (C), Phone: 306-668-0505, Email: knox@sasktel.net Robin Menzies, MBBS FRCPsych (UK) FRCP (C), Principal Investigator Tamara Hinz, MD, Sub-Investigator Mansfield Mela, MD, Sub-Investigator Curtis Chicoine, MD, Sub-Investigator Hyun Lim, PhD, Sub-Investigator
Additional Information
More information on the PTTM study
Related 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. Epub 2007 Jun 22. 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. Pitman RK. Post-traumatic stress disorder, hormones, and memory. Biol Psychiatry. 1989 Jul;26(3):221-3. Review. 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. 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.
Starting date: February 2010
Last updated: June 19, 2011
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