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NCT00709735 · ClinicalTrials.gov registry record · Phase 4
A Psychophysiologic Study of Weakening Traumatic Combat Memories With Post-Reactivation Propranolol
A Phase 4 study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT00709735: Completed Phase 4 study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
NCT00709735 is a Phase 4 study of Post Traumatic Stress Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00709735, a Phase 4 study of Post Traumatic Stress Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study Summary
The consolidation of learning is enhanced by adrenalin and other stress hormones. This memory enhancing effect is opposed by propranolol. In posttraumatic stress disorder (PTSD), a psychologically traumatic event may overstimulate stress hormones such as adrenalin, which in turn overly strengthen consolidation of the memory of the event, leading to an excessively powerful and persistent memory. Administration of propranolol after a psychologically traumatic event could reduce subsequent PTSD. Unfortunately, there exists a window of opportunity for influencing the consolidation of a traumatic event into long-term memory. In persons who have already developed PTSD, this would have closed months or years earlier. However, recent developments in animal research suggest that reactivation (retrieval) of a consolidated memory can return it to a labile state, from which it must be restabilized in order to persist. This process, which has been termed "reconsolidation," can be reduced in animals by propranolol. In a preliminary study performed by the PI and colleagues in Canada, civilian participants with PTSD described the traumatic event during a script preparation session, which served to reactivate their traumatic memory. They then received either propranolol or placebo. A week later, during script-driven imagery of their traumatic events, physiologic responses were smaller in the participants who had received post-reactivation propranolol compared to placebo, suggesting that the traumatic memory had been weakened by the propranolol. These results suggest that that post-reactivation propranolol recapitulates its effects on consolidation, this time by blocking reconsolidation of the traumatic memory. Several important questions remain unanswered. First, does propranolol also weaken traumatic memories in combat-related PTSD? Second, does this weakening effect only occur when the propranolol is given after combat memory reactivation? If not, this would refute the reconsoli
Primary Outcome
The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven imagery of traumatic combat events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Re
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Propranolol
Study Locations (3)
Massachusetts
- VA Medical Center - Bedford
- Massachusetts General Hospital - Boston
New Hampshire
- VA Medical Center - Manchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-08 |
| Phase | Phase 4 |
What the finished NCT00709735 record still lists
NCT00709735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00709735 reports a single indexed study location in Massachusetts, New Hampshire.
Frequently Asked Questions
What is clinical trial NCT00709735 about?
NCT00709735 is a clinical study titled "A Psychophysiologic Study of Weakening Traumatic Combat Memories With Post-Reactivation Propranolol". The consolidation of learning is enhanced by adrenalin and other stress hormones. This memory enhancing effect is opposed by propranolol. In posttraumatic stress disorder (PTSD), a psychologically traumatic event may overstimulate stress hormones such as adrenalin, which in turn overly strengthen co...
What is the current status of trial NCT00709735?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2007-05. Estimated completion is 2010-08.
What conditions does trial NCT00709735 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT00709735?
The interventions under investigation include: Placebo (DRUG), Propranolol (DRUG).
Who is sponsoring clinical trial NCT00709735?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00709735 being conducted?
This trial has 3 study locations across Massachusetts, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00709735's enrollment target sits among peer trials
23 227th of 262 higher than 35 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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