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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 7, 2005 | ||||
| Last Updated Date | September 25, 2008 | ||||
| Start Date ICMJE | August 2004 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Psychophysiologic responses to traumatic recollection [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Psychophysiologic responses to traumatic recollection, Months 1 and 3 | ||||
| Change History | Complete list of historical versions of study NCT00158262 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Post Traumatic Stress Disorder symptoms [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Post Traumatic Stress Disorder symptoms, Months 1 and 3 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Propranolol on Preventing Post-Traumatic Stress Disorder | ||||
| Official Title ICMJE | Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol | ||||
| Brief Summary | This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of post-traumatic stress disorder in acutely traumatized individuals. |
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| Detailed Description | Post-Traumatic 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 propranolol's 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Post-Traumatic Stress Disorder | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Propranolol | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 128 | ||||
| Estimated Completion Date | May 2009 | ||||
| Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00158262 | ||||
| Responsible Party | Roger Pitman, MD, Harvard Medical School | ||||
| Study ID Numbers ICMJE | R01 MH68603, DATR AD-TS | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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