Propranolol Treatment of Traumatic Memories (PTTM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Mela, Mansfield, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mela, Mansfield, M.D.
ClinicalTrials.gov Identifier:
NCT01069159
First received: February 13, 2010
Last updated: June 19, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Traumatic Memory
Posttraumatic Stress Disorder
Drug: Propranolol Hydrochloride
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Propranolol Treatment of Traumatic Memories (PTTM)

Resource links provided by NLM:


Further study details as provided by Mela, Mansfield, M.D.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoint will be changes between the treatment and posttreatment score in the other scales used - MINI, ZAS, ZDS and NIHS. [ Time Frame: Visit 2 (Week 4) ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Names:
  • APO-PROPRANOLOL (DIN 00402753)
  • INDERAL LA (DIN 02042231)
  • PROPRANOLOL
  • PROPRANOLOL LONG-ACTING
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.
Drug: 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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069159

Contacts
Contact: Robin Menzies, MBBS FRCPsych (UK) FRCP (C) 306-668-0505 knox@sasktel.net

Locations
Canada, Saskatchewan
Knox Manse Recruiting
Saskatoon, Saskatchewan, Canada, S7N 2M5
Contact: Robin Menzies, MBBS FRCPsych (UK) FRCP (C)    306-668-0505    knox@sasktel.net   
Principal Investigator: Robin Menzies, MBBS FRCPsych (UK) FRCP (C)         
Sub-Investigator: Tamara Hinz, MD         
Sub-Investigator: Mansfield Mela, MD         
Sub-Investigator: Curtis Chicoine, MD         
Sub-Investigator: Hyun Lim, PhD         
Sponsors and Collaborators
Mela, Mansfield, M.D.
Investigators
Principal Investigator: Robin Menzies, MBBS FRCPsych (UK) FRCP (C)
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Robin Menzies, Knox Manse
ClinicalTrials.gov Identifier: NCT01069159     History of Changes
Other Study ID Numbers: 505-2010
Study First Received: February 13, 2010
Last Updated: June 19, 2011
Health Authority: Canada: Health Canada

Keywords provided by Mela, Mansfield, M.D.:
Traumatic memory
Traumatic memories
Traumatic memories and associated symptoms
Posttraumatic Stress Disorder
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 30, 2014