Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

NCT00671099 | Completed Phase 3 DMC

• 1 other identifier: NDMC-TPOP-02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Posttraumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total score of Clinician-Administrated PTSD Scale

  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

Study Arms (2)

1

EXPERIMENTAL

Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid

Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Omega-3 Polyunsaturated Fatty Acid DIETARY_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.

1

Placebo DIETARY_SUPPLEMENT

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Japan Science and Technology Agency: lead
• University of Toyama: collaborator
• Chiba University: collaborator

Study Sites (1)

National Disaster Medical Center

Tachikawa, Tokyo, 1900014, Japan

Location

Related Publications (5)

• 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.

  PMID: 23289548 BACKGROUND

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• 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.

  PMID: 35141873 DERIVED

• 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.

  PMID: 26335087 DERIVED

• 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.

  PMID: 26151924 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Yutaka Matsuoka, M.D.,Ph.D.

  National Disaster Medical Center, Tachikawa, Tokyo ,Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

JP (1)