Propranolol Treatment of Traumatic Memories (PTTM)

NCT01069159 | Unknown

• 1 other identifier: 505-2010
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Propranolol Hydrochloride DRUG

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.

Also known as: APO-PROPRANOLOL (DIN 00402753), INDERAL LA (DIN 02042231), PROPRANOLOL, PROPRANOLOL LONG-ACTING

Propranolol

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mela, Mansfield, M.D.: lead

Study Sites (1)

Knox Manse

Saskatoon, Saskatchewan, S7N 2M5, Canada

RECRUITING

Related 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. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.

  PMID: 17588604 BACKGROUND

• 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. doi: 10.1038/35021052.

  PMID: 10963596 BACKGROUND

• Pitman RK. Post-traumatic stress disorder, hormones, and memory. Biol Psychiatry. 1989 Jul;26(3):221-3. doi: 10.1016/0006-3223(89)90033-4. No abstract available.

  PMID: 2545287 BACKGROUND

• 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. doi: 10.1016/s0006-3223(01)01279-3.

  PMID: 11822998 BACKGROUND

• 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. doi: 10.1016/s0006-3223(03)00412-8.

  PMID: 14573324 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

306-668-0505; knox@sasktel.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: February 13, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

CA (1)