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

Phase 3

Completed

• Conditions: Posttraumatic Stress Disorder; Trauma
• Interventions: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid; Dietary Supplement: Placebo

• Registration Number: NCT00671099
• Lead Sponsor: Japan Science and Technology Agency

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

Study Timeline

• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Study Start: 2008-12
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility to 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Omega-3 Polyunsaturated Fatty Acid	Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Total score of Clinician-Administrated PTSD Scale	Three month

Secondary Outcome Measures

Name	Time	Method
D-serine	Three month, one month
L-serine	Three month, one month
DL-serine	Three month, one month
Activin	Three month, one month
TNF alpha: tumor necrosis factor alpha	Three month, one month
Number of days of leave taken from the time of injury	Three month
Incidence of diagnosis of PTSD (including partial PTSD)	Three month, one month
Buss-Perry Aggression Questionnaire (BAQ)	Three month, one month, baseline
Brain-derived neurotrophic factor (BDNF) in serum	Three month, one month
IL-6: interleukin 6	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
Score of Hospital Anxiety and Depression scale (HADS)	Three month, one month
Score of health related Quality of Life scale, SF-36	Three month, one month
Score of Conner-Davidson Resilience Scale (CD-RISC)	Three month, one month
NPY: neuropeptide Y	Three month, one month
Total score of Clinician-Administrated PTSD Scale (CAPS)	One month
DHEA: dehydroepiandrosterone	Three month, one month
IL-1 beta: interleukin 1 beta	Three month, one month

Trial Locations

Locations (1)

National Disaster Medical Center; 🇯🇵 Tachikawa, Tokyo, Japan