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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671099
• Other study ID #: NDMC-TPOP-02
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2008
• Last updated: January 20, 2014
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Japan Science and Technology Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ? ?GTP 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma

Intervention

Dietary Supplement:
• Omega-3 Polyunsaturated Fatty Acid
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.
• Placebo
Placebo

Locations

Country	Name	City	State
Japan	National Disaster Medical Center	Tachikawa	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Japan Science and Technology Agency	Chiba University, University of Toyama

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of Clinician-Administrated PTSD Scale		Three month	Yes
Secondary	Incidence of diagnosis of PTSD (including partial PTSD)		Three month, one month	Yes
Secondary	Total score of Montgomery Asberg Depression Rating Scale (MADRAS)		Three month, one month	Yes
Secondary	Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)		Three month, one month	Yes
Secondary	Autonomic response measured before, during and after script driven imagery and acoustic stimulation		Three month	Yes
Secondary	Score of Impact of Event Scale revised (IES-R)		Three month, one month	Yes
Secondary	Score of Hospital Anxiety and Depression scale (HADS)		Three month, one month	Yes
Secondary	Score of health related Quality of Life scale, SF-36		Three month, one month	No
Secondary	Score of Conner-Davidson Resilience Scale (CD-RISC)		Three month, one month	Yes
Secondary	Brain-derived neurotrophic factor (BDNF) in serum		Three month, one month	Yes
Secondary	Number of days of leave taken from the time of injury		Three month	No
Secondary	Buss-Perry Aggression Questionnaire (BAQ)		Three month, one month, baseline	No
Secondary	Total score of Clinician-Administrated PTSD Scale (CAPS)		One month	Yes
Secondary	DHEA: dehydroepiandrosterone		Three month, one month	No
Secondary	NPY: neuropeptide Y		Three month, one month	No
Secondary	IL-1 beta: interleukin 1 beta		Three month, one month	No
Secondary	IL-6: interleukin 6		Three month, one month	No
Secondary	TNF alpha: tumor necrosis factor alpha		Three month, one month	No
Secondary	D-serine		Three month, one month	No
Secondary	L-serine		Three month, one month	No
Secondary	DL-serine		Three month, one month	No
Secondary	Activin		Three month, one month	No