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Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study

NCT ID: NCT00671489

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma Posttraumatic Stress Disorder

Keywords

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Patients high-energy admitted intensive care unit motor vehicle accident falling from height other accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility contact patients with injury in 240 hours, and dosing in oral use
4. Physical and metal status to possible understands scope and contents in the trial and gets informed consent

Exclusion Criteria

1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
2. Cognitive impairment: Mini Mental State Examination \< 24
3. Heavy drinker or 100IU/L ≦ γGTP in administration
4. Heavy smoker (over 40 cigarettes per day)
5. History and current suspicion in diagnosis of psychosis and bipolar I disorder
6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
10. Habit of eating fish over 4 times per week
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toyama

OTHER

Sponsor Role collaborator

Chiba University

OTHER

Sponsor Role collaborator

Japan Science and Technology Agency

OTHER

Sponsor Role lead

Responsible Party

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National Disaster Medical Center and National Center of Neurology and Psychiatry

Principal Investigators

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Yutaka Mastuoka, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Locations

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National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Tachikawa, Tokyo, Japan

Site Status

Countries

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Japan

References

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Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Hashimoto K, Hamazaki T. Omega-3 fatty acids for secondary prevention of posttraumatic stress disorder after accidental injury: an open-label pilot study. J Clin Psychopharmacol. 2010 Apr;30(2):217-9. doi: 10.1097/JCP.0b013e3181d48830. No abstract available.

Reference Type RESULT
PMID: 20520307 (View on PubMed)

Matsuoka Y. Clearance of fear memory from the hippocampus through neurogenesis by omega-3 fatty acids: a novel preventive strategy for posttraumatic stress disorder? Biopsychosoc Med. 2011 Feb 8;5:3. doi: 10.1186/1751-0759-5-3.

Reference Type RESULT
PMID: 21303552 (View on PubMed)

Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Hamazaki T, Hashimoto K. Potential role of brain-derived neurotrophic factor in omega-3 Fatty Acid supplementation to prevent posttraumatic distress after accidental injury: an open-label pilot study. Psychother Psychosom. 2011;80(5):310-2. doi: 10.1159/000322980. Epub 2011 Jun 30. No abstract available.

Reference Type RESULT
PMID: 21720194 (View on PubMed)

Other Identifiers

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NDMC-TPOP-01

Identifier Type: -

Identifier Source: org_study_id