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The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

ABSTRACT: Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive symptoms in Taiwan and Japan, to provide evidence available for Asia. The rationale and protocol of this trial are reported here.The Synchronized Trial on Expectant Mothers with Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) is a multicenter, double-blind, parallel group, randomized controlled trial. Participants will be randomized to either the omega-3 PUFAs arm (1,200 mg eicosapentaenoic acid and 600 mg docosahexaenoic acid daily) or placebo arm. Primary outcome is total score on the Hamilton Rating Scale for Depression (HAMD) at 12 weeks after the start of the intervention. We will randomize 56 participants to have 90 % power to detect a 4.7-point difference in mean HAMD scores with omega-3 PUFAs compared with placebo. Because seafood consumption varies across countries and this may have a major effect on the efficacy of omega-3 PUFA supplementation, 56 participants will be recruited at each site in Taiwan and Japan, for a total number of 112 participants. Secondary outcomes include depressive symptoms at 1 month after childbirth, diagnosis of major depressive disorder, changes in omega-3 PUFAs concentrations and levels of biomarkers at baseline and at 12 weeks' follow-up, and standard obstetric outcomes. Data analyses will be by intention to treat. The trial was started in June 2014 and is scheduled to end in February 2018.The trial is expected to provide evidence that can contribute to promoting mental health among mothers and children in Asian populations.Clinicaltrials.gov: NCT02166424 . Registered 15 June 2014; University Hospital Medical Information Network (UMIN) Center: UMIN000017979. Registered 20 May 2015.

SUBMITTER: Nishi D

PROVIDER: S-EPMC5024529 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

Nishi Daisuke D Su Kuan-Pin KP Usuda Kentaro K Chiang Yi-Ju Jill YJ Guu Tai-Wei TW Hamazaki Kei K Nakaya Naoki N Sone Toshimasa T Sano Yo Y Tachibana Yoshiyuki Y Ito Hiroe H Isaka Keiich K Hashimoto Kenji K Hamazaki Tomohito T Matsuoka Yutaka J YJ

BMC psychiatry 20160915 1

<h4>Background</h4>Maternal depression can be harmful to both mothers and their children. Omega-3 polyunsaturated fatty acid (PUFA) supplementation has been investigated as an alternative intervention for pregnant women with depressive symptoms because of the supporting evidence from clinical trials in major depression, the safety advantage, and its anti-inflammatory and neuroplasticity effects. This study examines the efficacy of omega-3 PUFA supplementation for pregnant women with depressive s ...[more]

PMID: 27630014

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Project description:Low n-3 polyunsaturated fatty acids (PUFAs) has been linked to depression, but the preventive effect of n-3PUFAs supplementation on maternal depression needs further investigation. We aimed to evaluate the efficacy of a daily dose of n-3 PUFAs supplementation (fish oil) on the prevention of postpartum depression (PPD).A randomized, placebo-controlled, double blind trial was designed and nested into a cohort study conducted in Rio de Janeiro, Brazil. Sixty pregnant women identified as being at risk for PPD were invited and randomly assigned to receive fish oil capsules [1.8 g (1.08 g of Eicosapentaenoic (EPA) and 0.72 g of Docosapentaenoic (DHA) acids)] or placebo (control). The Edinburgh Postnatal Depression Scale (EPDS) was scored at 5-13 (T0, baseline), 22-24 (T1), 30-32 weeks of gestation (T2) and 4-6 weeks' postpartum (T3). Supplementation started at week 22-24 of gestation (T1) and lasted for 16 weeks. Serum fatty acids were assayed to evaluate compliance. Prevalence of EPDS ?11 was the primary outcome, and mean and changes in EPDS score, length of gestation, and birth weight the secondary outcomes. Linear mixed-effect (LME) and random-intercept logistic regression models were performed to test the effect of fish oil supplementation on prevalence of EPDS ?11 and EPDS scores variation.In intention-to-treat (ITT) analysis, at 30-32 weeks' gestation women in the fish oil presented higher serum concentration of EPA, DHA and lower n-6/n-3 ratio comparing to the control group. There were no differences between intervention and control groups in the prevalence of EPDS ?11, EPDS scores over time, or in changes in EPDS scores from pregnancy to postpartum in either the ITT or per-protocol analyses. Women in the fish oil group with previous history of depression presented a higher reduction on the EPDS score from the second to the third trimester in the fish oil comparing to the control group in the ITT analyses [-1.0 (-3.0-0.0) vs. -0.0 (-1.0-3.0), P = 0.038). These results were confirmed on the LME model (? = -3.441; 95%CI: -6.532- -0.350, P = 0.029).Daily supplementation of 1.8 g of n-3 PUFAs during 16 weeks did not prevent maternal depressive symptoms in a sample of Brazilian women.ClinicalTrials.gov Identifier: NCT01660165 . Retrospectively registered on 24 May 2012.

Project description:BackgroundPre-eclampsia is a pregnancy disorder, characterised by hypertension and multisystem complications in the mother. The adverse outcomes of pre-eclampsia include severe hypertension, stroke, renal and hepatic injury, haemorrhage, fetal growth restriction and even death. The optimal time to instigate delivery to prevent morbidity when pre-eclampsia occurs between 34 and 37?weeks' gestation, without increasing problems related to infant immaturity or complications, remains unclear.Methods/designThe PHOENIX trial is a non-masked, randomised controlled trial, comparing planned early delivery (with initiation of delivery within 48?h of randomisation) with usual care (expectant management) in women with pre-eclampsia between 34+?0 and 36+?6 weeks' gestation. The primary objectives of the trial are to determine if planned delivery reduces adverse maternal outcomes, without increasing the short-term harm to infants (composite of perinatal deaths or neonatal unit admissions up to infant hospital discharge) or impacting long-term infant neurodevelopmental status at 2 years corrected age (Parent Report of Cognitive Abilities-Revised).DiscussionCurrent practice in the UK at the time of trial commencement for management of pre-eclampsia varies by gestation. Previous trials have shown that in women with pre-eclampsia after 37?weeks of gestion, delivery is initiated, as maternal complications are reduced without increasing fetal risks. Prior to 34?weeks of gestation, usual management aims to prolong pregnancy for fetal benefit, unless severe complications occur, necessitating preterm delivery. This trial aims to address the uncertainty for women where the balance of benefits and risks of delivery compared to expectant management are uncertain. Previous trials in this area have been undertaken, but have not provided a definitive answer, and the research question remains active. The results of this trial are expected to influence clinical practice internationally, through direct adoption and by incorporation into guidelines in countries with similar settings.Trial registrationISRCTN01879376 . Registered on 25 November 2013.

Project description:BACKGROUND:Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan. OBJECTIVE:This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms. METHODS:In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory. RESULTS:This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019. CONCLUSIONS:Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students. TRIAL REGISTRATION:Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15164.

Dataset Information

The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

Publications

The synchronized trial on expectant mothers with depressive symptoms by omega-3 PUFAs (SYNCHRO): Study protocol for a randomized controlled trial.

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