Back to resultsTachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Primary Purpose
Trauma, Posttraumatic Stress Disorder
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Omega-3 Polyunsaturated Fatty Acid
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Trauma focused on measuring Patients, with high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident
Eligibility Criteria
Inclusion Criteria:
- 18 plus years
- A native Japanese speaking ability
- Possibility to 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
Sites / Locations
- National Disaster Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
Placebo
Outcomes
Primary Outcome Measures
Total score of Clinician-Administrated PTSD Scale
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
NCT ID
NCT00671099
First Posted
May 1, 2008
Last Updated
January 20, 2014
Sponsor
Japan Science and Technology Agency
Collaborators
University of Toyama, Chiba University
1. Study Identification
Unique Protocol Identification Number
NCT00671099
Brief Title
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Official Title
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 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, with high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Total score of Clinician-Administrated PTSD Scale
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 to 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 Matsuoka, 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
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
1900014
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23289548
Citation
Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial. BMC Psychiatry. 2013 Jan 5;13:8. doi: 10.1186/1471-244X-13-8.
Results Reference
background
PubMed Identifier
35141873
Citation
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
Results Reference
derived
PubMed Identifier
26335087
Citation
Matsuoka Y, Nishi D, Hamazaki K, Yonemoto N, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Docosahexaenoic acid for selective prevention of posttraumatic stress disorder among severely injured patients: a randomized, placebo-controlled trial. J Clin Psychiatry. 2015 Aug;76(8):e1015-22. doi: 10.4088/JCP.14m09260.
Results Reference
derived
PubMed Identifier
26151924
Citation
Matsuoka Y, Nishi D, Tanima Y, Itakura M, Kojima M, Hamazaki K, Noguchi H, Hamazaki T. Serum pro-BDNF/BDNF as a treatment biomarker for response to docosahexaenoic acid in traumatized people vulnerable to developing psychological distress: a randomized controlled trial. Transl Psychiatry. 2015 Jul 7;5(7):e596. doi: 10.1038/tp.2015.89.
Results Reference
derived
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Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
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