Evidence map›Paper›PMID 23289548›Full record

Trial reportBMC psychiatry2013

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

Yutaka Matsuoka, Daisuke Nishi, Naohiro Yonemoto, Kei Hamazaki, Kenta Matsumura, Hiroko Noguchi, Kenji Hashimoto, Tomohito Hamazaki

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00671099 (Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00671099 phase3completednot on this map

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

TypeinterventionalSponsorJapan Science and Technology AgencyRan2008 to 2013Enrolled110ConditionsTrauma, Posttraumatic Stress DisorderArmsOmega-3 Polyunsaturated Fatty Acid, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Yutaka MatsuokaDepartment of Psychiatry, National Disaster Medical Center, 3256 Midoricho, 190-0014, Tachikawa, Tokyo, Japan. yutaka@ncnp.go.jp
Daisuke Nishi
Naohiro Yonemoto
Kei Hamazaki
Kenta Matsumura
Hiroko Noguchi
Kenji Hashimoto
Tomohito Hamazaki
Japan Science and Technology Agency · JPNational Disaster Medical Center · JPNational Institute of Mental Health · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. METHODS/

designThe Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. DISCUSSION: This study promises to be the first trial to provide a novel prevention strategy for PTSD among traumatized people.

trial registrationClinicalTrials.gov Identifier NCT00671099.

Indexed as

Brain-Derived Neurotrophic FactorDietary SupplementsDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidFatty Acids, Omega-3Fatty Acids, UnsaturatedHippocampusHumansPsychiatric Status Rating ScalesPsychological TestsStress Disorders, Post-TraumaticWounds and InjuriesBrain-Derived Neurotrophic FactorDocosahexaenoic AcidsEicosapentaenoic AcidFatty Acids, Omega-3Fatty Acids, Unsaturated

Identifiers

PMID23289548
PMCPMC3598223
OpenAlexW2007543422

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.