Whether disrupting reconsolidation by a noradrenergic β-blocker provides long-term relief of PTSD symptoms in traumatized healthcare workers.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary output will be (a) the percent change in PTSD diagnosis and (b) the
decrease in frequency and severity of PTSD symptoms, from baseline to
post-treatment and follow-up.
Secondary outcome
Not applicable.
Background summary
Memory for traumatic experiences is particularly strong and resistant to
change. However, recent years have witnessed rapidly emerging evidence for the
plasticity of fear memories. Upon its retrieval memory may be rendered labile
and vulnerable to the disruptive effects of amnestic agents: this process is
referred to as *disrupting reconsolidation* and may point to a novel
therapeutic strategy for the permanent reduction of fear in patients suffering
from posttraumatic stress disorder.
Study objective
Whether disrupting reconsolidation by a noradrenergic β-blocker provides
long-term relief of PTSD symptoms in traumatized healthcare workers.
Study design
A non-concurrent multiple-baseline case-series design.
Intervention
A single reactivation session of trauma memory followed by the administration
of 40 mg of the noradrenergic β-blocker propranolol.
Study burden and risks
Patients are receiving a short treatment that is expected to diminish their
PTSD symptoms. Reliving the traumatic experience through sensory reality causes
symptoms of arousal and fear, but these are of short duration and harmless.
Exposing individuals to fear-inducing situations is common in treatment for
PTSD. Based on the Summary of Product Characteristics we expect that
propranolol HCl will be well tolerated and do not anticipate any serious
adverse events.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
1. aged between 18 and 65 years;
2. a primary diagnosis of PTSD according to DSM-V
3. a score of > 20 on the Post-traumatic Symptom Scale at screening
Exclusion criteria
1. other relevant treatment for PTSD within 3 months before start of the study
2. start of new medication within 3 months before start of study
3. life-time psychosis
4. acute suicide risk
5. current state of asthma or COPD, which necessitates medication use
6. cardiovascular diseases or irregular heartbeat
7. hypotension or hypertension
8. pregnancy or breastfeeding
9. epilepsy
10. any medication contra-indicative of the use of propranolol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-003563-26-NL |
| CCMO | NL74799.018.20 |