Recruiting

Propranolol

Sponsor:

Mela, Mansfield, M.D.

Code:

NCT01069159

Conditions

Traumatic Memory

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Propranolol Hydrochloride

Placebo

Study Details

Brief 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.

Conditions

Traumatic Memory

Posttraumatic Stress Disorder

Study ID

NCT01069159

Start date

Feb, 2010

Status verified date

Jun, 2011

Completion date

Sep, 2011

Anticipated

Primary completion date

Sep, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Propranolol

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) 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.

placebo comparator: 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.

Interventions

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.

Primary outcome measure

  • 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. [ Time Frame: Visit 2 (Week 4) ]

Central Contacts and Locations

Central contacts

Robin Menzies, MBBS FRCPsych (UK) FRCP (C)

306-668-0505knox@sasktel.net

Locations

Knox Manse

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 2M5

Contacts

Robin Menzies, MBBS FRCPsych (UK) FRCP (C)

306-668-0505knox@sasktel.net

Principal Investigator:

Robin Menzies, MBBS FRCPsych (UK) FRCP (C)

More Information

Sponsor

Mela, Mansfield, M.D.

Last update posted

Jun 21, 2011

Last verified

Jun, 2011

Keywords

  • Traumatic memory
  • Traumatic memories
  • Traumatic memories and associated symptoms
  • Posttraumatic Stress Disorder
  • PTSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mela, Mansfield, M.D. on 2011-06-21.