Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158262
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2005-09-07
Brief Title:
Effect of Propranolol on Preventing Posttraumatic Stress Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Prophylaxis of Posttraumatic Stress Disorder With Post-Trauma Propranolol
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals
Detailed Description:
Posttraumatic Stress Disorder PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened PTSD is marked by clear biological changes as well as psychological symptoms Many people with PTSD repeatedly relive the trauma in the form of flashback episodes memories nightmares or frightening thoughts This study will assess the effect of post-trauma propranolol on reducing the incidence and severity of PTSD The study will also evaluate propranolols effectiveness as a preventive measure against subsequent PTSD symptoms
Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event Baseline psychometric and psychobiologic measurements will be collected Within 6 hours following the traumatic event participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo For the next 10 days participants will receive 120 mg of either long-acting propranolol or placebo twice daily A 9-day medication tapering will follow Participants will undergo psychophysiologic psychodiagnostic and psychometric testing for PTSD 1 and 3 months following the traumatic event
Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event Baseline psychometric and psychobiologic measurements will be collected Within 6 hours following the traumatic event participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo For the next 10 days participants will receive 120 mg of either long-acting propranolol or placebo twice daily A 9-day medication tapering will follow Participants will undergo psychophysiologic psychodiagnostic and psychometric testing for PTSD 1 and 3 months following the traumatic event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH068603 | NIH | None | httpsreporternihgovquickSearchR01MH068603 |