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| Tracking Information | |||||
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| First Received Date ICMJE | April 23, 2008 | ||||
| Last Updated Date | May 4, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Total score of Clinician-Administrated PTSD Scale (CAPS) [ Time Frame: Three month ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Total score of Clinical-Administrated PTSD Scale (CAPS) [ Time Frame: Three month ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00671489 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study | ||||
| Official Title ICMJE | Phase 2 Study of Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study | ||||
| Brief Summary | The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries. |
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| Detailed Description | Accidental injuries, mostly motor vehicle accident, in civilian population are frequent events. For instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness and the major diagnoses are post-traumatic stress disorder (PTSD) and depressive disorder. Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries. We evaluate efficacy and safety of Omega-3 PUFA for the secondary prevention of Posttraumatic Stress Disorder (PTSD) and related psychiatric illness in patients with accidental injury. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week. |
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| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 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 and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00671489 | ||||
| Responsible Party | Matsuoka Yutaka, National Disaster Medical Center and National Center of Neurology and Psychiatry | ||||
| Study ID Numbers ICMJE | NDMC-TPOP-01 | ||||
| Study Sponsor ICMJE | Japan Science and Technology Agency | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Japan Science and Technology Agency | ||||
| Verification Date | May 2009 | ||||
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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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