NCT00671489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 3, 2012

Status Verified

May 1, 2009

Enrollment Period

9 months

First QC Date

April 23, 2008

Last Update Submit

July 2, 2012

Conditions

TraumaPosttraumatic Stress Disorder

Keywords

Patientshigh-energyadmittedintensive care unitmotor vehicle accidentfalling from heightother accident

Outcome Measures

Primary Outcomes (1)

  • Total score of Clinician-Administrated PTSD Scale (CAPS)

    Three month

Secondary Outcomes (21)

  • Incidence of diagnosis of PTSD (including partial PTSD)

    Three month, one month

  • Total score of Montgomery Asberg Depression Rating Scale (MADRAS)

    Three month, one month

  • Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)

    Three month, one month

  • Autonomic response measured before, during and after script driven imagery and acoustic stimulation

    Three month

  • Score of Impact of Event Scale revised (IES-R)

    Three month, one month

  • +16 more secondary outcomes

Interventions

Omega-3 Polyunsaturated Fatty AcidDIETARY_SUPPLEMENT

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Tachikawa, Tokyo, 190-0014, Japan

Location

Related Publications (3)

  • 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.

    PMID: 20520307RESULT

  • 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.

    PMID: 21303552RESULT

  • 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.

    PMID: 21720194RESULT

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-Traumatic

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Yutaka Mastuoka, M.D., Ph.D.

    National Disaster Medical Center, Tachikawa, Tokyo ,Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

May 5, 2008

Study Start

May 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 3, 2012

Record last verified: 2009-05

Locations

JP(1)