A Phase 2 interventional study of Propranolol Hydrochloride and Placebo in Trauma and Stressor Related Disorders, Post-traumatic Stress Disorders and Adjustment Disorders, sponsored by Douglas Mental Health University Institute. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Douglas Mental Health University Institute · Phase 2, Interventional, and Treatment
Police officers, correctional service officers, and 911-operators are at increased risk for suffering from trauma-related disorders due to their direct and indirect exposure to life-threatening events, such as shootings, violent assaults, or car accidents, among others. Typical treatments for post-traumatic stress disorders include psychotherapy and pharmacological therapies (i.e., antidepressants). Although these interventions are effective for many sufferers, they all have limitations. Thus, the investigators propose to explore the usefulness of a new therapeutic technique, reconsolidation blockade, which involves reactivating the trauma memory while under the influence of propranolol. Objectives and hypotheses: To explore the efficacy and cost-effectiveness of reconsolidation blockade therapy as an adjunct treatment for trauma- and stressor-related disorders as defined in the Diagnostic and Statistical Manual Mental Disorders-5. The investigators hypothesize that, compared to the control group, 5 weekly trauma-memory reactivations under propranolol treatment will confer a significant reduction in trauma-related symptoms and significantly more health-related economic benefits. Stress symptoms and health-related costs will be assessed at 7, 26 and 52 weeks after study inclusion. In this study, the investigators will also explore the effects of reconsolidation blockade with propranolol on various neuropsychological functions.
Exclusion Criteria:
1mg / kg of propranolol hydrochloride administered as a capsule 60 minutes prior to memory reactivation
Drug: Propranolol Hydrochloride
Placebo manufactured as a capsule to mimic 1mg/kg of propranolol hydrochloride administered 60 minutes prior to memory reactivation
Drug: Placebo
1mg / kg of propranolol hydrochloride, oral capsule
Also known as: Teva-propranolol
1mg / kg of matched placebo, oral capsule
EuroQol five dimensions questionnaire with five-level scale
This questionnaire is a standardized instrument for measuring generic health status
Time frame: The weighted average of the questionnaire responses will be calculated over a 12 month period
Post-traumatic Checklist for the Diagnostic and Statistical Manual for Mental Disorders - 5th edition (PCL-5)
Measure of trauma and stressor related symptoms
Time frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Hopkins Symptom Checklist - 25 (HSCL - 25).
Measure of depression and anxiety symptom severity
Time frame: Change from baseline (week 0) to weeks 1, 2, 3, 4 , 5, 7, 26, and 52.
Operational Police Stress Questionnaire (PSQ-OP)
Measure of severity of occupational stress
Time frame: Change from baseline (week 0) to weeks 7, 26, and 52.
Social Functioning Questionnaire (SFQ)
Measure of psycho-social functional
Time frame: Change from baseline (week 0) to weeks 7, 26, and 52.
Rey's 15-Item Memory test
Measure of verbal learning and memory
Time frame: Change from baseline (week 0) to weeks 7 and 52.
The Logical Memory subtest of the Wechsler Memory Scale - III
Measure of verbal learning and memory
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Trail Making Test
Measure of mental flexibility
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Color-Word Interference Test of the Delis-Kaplan Executive Function System
Measure of selective attention
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Coding subtest of the Wechsler Adult Intelligence Scale-IV
Measure of working memory
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Attention subtest of the Paced Auditory Serial Addition Test (PASAT)
Measure of working memory, divided attention, and information processing speed
Time frame: Change from baseline (week 0) to weeks 7 and 52.
D2 Test of attention
Measure of selective and sustained attention
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Verbal Fluency Test
Measure of verbal ability and executive control
Time frame: Change from baseline (week 0) to weeks 7 and 52.
Subjective Units of Distress Scale
Measure of subjective distress from exposure to an event
Time frame: Changes from week 1 to weeks 2, 3, 4 and 5.
Plan to share: Undecided
No publications or documents are linked to this record.
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Douglas Mental Health University Institute