Posttraumatic Stress Disorder
Conditions
Brief summary
The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.
Interventions
DRUGPropranolol
1mg per Kg (participant weight)
DRUGShort acting + long acting propranolol + memory reactivation
After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.
Sponsors
Canadian Institutes of Health Research (CIHR)
Douglas Mental Health University Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Suffer from chronic PTSD for at least 6 consecutive months; * Obtain a score of 33 or more on the Impact of Events Scale-Revised: * For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal; * Accept to not commence taking new medications on a regular basis during the study.
Exclusion criteria
* Hypotension; * Cardiac rhythm below 55 beats per minute; * Medical conditions that contraindicates the administration of propranolol; * Previous adverse reaction to, or non-compliance with, beta-blockers; * Current use of medication that may involve potentially dangerous interactions with propranolol; * Any medication that can have an impact on cardiac rhythm; * Women who are breast feeding; * Past or present bipolar disorder or psychosis, * Present substance abuse or dependence, suicidal ideation; * Participating in psychotherapy other than support psychotherapy; * An average score above 20 on the Dissociative Experience Scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electromyogram | Two weeks post-treatment |
| Heart rate | Two weeks post-treatment |
| Skin conductance | Two weeks post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 2 to 26 weeks | Quality of life assessments will be conducted 2 to 26 weeks following randomization |
| Psychophysiological assessments | 26 weeks | Psychophysiological assessments will be repeated 26 weeks following randomization |
| Memory Experience | 2 to 26 weeks | The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization |
| PTSD symptom levels | 2 to 26 weeks | PTSD symptom levels will be assessed 2 to 26 weeks after randomization |
Countries
Canada
Contacts
Primary ContactAlain R Brunet, Ph.D.
Outcome results
None listed