PatientsVille.com LogoPatientsVille.com

Traumatic Memory | Propranolol Treatment of Traumatic Memories (PTTM)

Traumatic Memory research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Memory

Posttraumatic Stress Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Propranolol HydrochlorideThe 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.

Drug:PlaceboThe 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropranololThe protocol of the study requires that two doses of propranolol (regular propranolol 40 mg followed two hours later by long-acting propranolol 60 mg) 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 propranolol.

PlaceboThe 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.

Study Status

Unknown status

Start Date: February 2010

Completed Date: September 2011

Phase: N/A

Type: Interventional

Design:

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.

Study sponsors, principal investigator, and references

Principal Investigator: Robin Menzies, MBBS FRCPsych (UK) FRCP (C)

Lead Sponsor: Mela, Mansfield, M.D.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01069159

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.

Discuss Propranolol