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

Primary Purpose

Trauma, Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Omega-3 Polyunsaturated Fatty Acid
Sponsored by
Japan Science and Technology Agency
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma focused on measuring Patients, high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Outcomes

Primary Outcome Measures

Total score of Clinician-Administrated PTSD Scale (CAPS)

Secondary Outcome Measures

Incidence of diagnosis of PTSD (including partial PTSD)
Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
Autonomic response measured before, during and after script driven imagery and acoustic stimulation
Score of Impact of Event Scale revised (IES-R)
Score of Hospital Anxiety and Depression scale (HADS)
Score of health related Quality of Life scale, SF-36
Score of Conner-Davidson Resilience Scale (CD-RISC)
Brain-derived neurotrophic factor (BDNF) in serum
Number of days of leave taken from the time of injury
Buss-Perry Aggression Questionnaire (BAQ)
Total score of Clinician-Administrated PTSD Scale (CAPS)
DHEA: dehydroepiandrosterone
NPY: neuropeptide Y
IL-1 beta: interleukin 1 beta
IL-6: interleukin 6
TNF alpha: tumor necrosis factor alpha
D-serine
L-serine
DL-serine
Activin

Full Information

First Posted
April 23, 2008
Last Updated
July 2, 2012
Sponsor
Japan Science and Technology Agency
Collaborators
University of Toyama, Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT00671489
Brief Title
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
Official Title
Phase 2 Study of Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Science and Technology Agency
Collaborators
University of Toyama, Chiba University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Posttraumatic Stress Disorder
Keywords
Patients, high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Polyunsaturated Fatty Acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total score of Clinician-Administrated PTSD Scale (CAPS)
Time Frame
Three month
Secondary Outcome Measure Information:
Title
Incidence of diagnosis of PTSD (including partial PTSD)
Time Frame
Three month, one month
Title
Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
Time Frame
Three month, one month
Title
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
Time Frame
Three month, one month
Title
Autonomic response measured before, during and after script driven imagery and acoustic stimulation
Time Frame
Three month
Title
Score of Impact of Event Scale revised (IES-R)
Time Frame
Three month, one month
Title
Score of Hospital Anxiety and Depression scale (HADS)
Time Frame
Three month, one month
Title
Score of health related Quality of Life scale, SF-36
Time Frame
Three month, one month
Title
Score of Conner-Davidson Resilience Scale (CD-RISC)
Time Frame
Three month, one month
Title
Brain-derived neurotrophic factor (BDNF) in serum
Time Frame
Three month, one month
Title
Number of days of leave taken from the time of injury
Time Frame
Three month
Title
Buss-Perry Aggression Questionnaire (BAQ)
Time Frame
Three month, one month, baseline
Title
Total score of Clinician-Administrated PTSD Scale (CAPS)
Time Frame
One month
Title
DHEA: dehydroepiandrosterone
Time Frame
Three month, one month
Title
NPY: neuropeptide Y
Time Frame
Three month, one month
Title
IL-1 beta: interleukin 1 beta
Time Frame
Three month, one month
Title
IL-6: interleukin 6
Time Frame
Three month, one month
Title
TNF alpha: tumor necrosis factor alpha
Time Frame
Three month, one month
Title
D-serine
Time Frame
Three month, one month
Title
L-serine
Time Frame
Three month, one month
Title
DL-serine
Time Frame
Three month, one month
Title
Activin
Time Frame
Three month, one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutaka Mastuoka, M.D., Ph.D.
Organizational Affiliation
National Disaster Medical Center, Tachikawa, Tokyo ,Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Disaster Medical Center, Tachikawa, Tokyo ,Japan
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20520307
Citation
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.
Results Reference
result
PubMed Identifier
21303552
Citation
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.
Results Reference
result
PubMed Identifier
21720194
Citation
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.
Results Reference
result

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

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