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A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.

ABSTRACT: OBJECTIVE:Studies of depressed psychiatric patients have suggested that antidepressant efficacy can be increased by adding eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish oils. The purpose of this study was to determine whether the addition of EPA improves the response to sertraline in depressed patients with or at high risk for coronary heart disease (CHD). METHODS:Between May 2014 and June 2018, 144 patients with DSM-5 major depressive disorder seen at the Washington University School of Medicine with or at high risk for CHD were randomized to receive either 50 mg/d of sertraline and 2 g/d of EPA or 50 mg/d of sertraline and corn oil placebo capsules for 10 weeks. The Beck Depression Inventory II (BDI-II) was the primary outcome measure. RESULTS:After 10 weeks of treatment, there were no differences between the arms on the mean baseline-adjusted BDI-II (placebo, 10.3; EPA, 12.1; P = .22), the 17-item Hamilton Depression Rating Scale (placebo, 7.2; EPA, 8.0; P = .40), or the 10-week remission rate (BDI-II score ? 8: placebo, 50.6%; EPA, 46.7%; odds ratio = 0.85; 95% CI, 0.43 to 1.68; P = .63). CONCLUSIONS:Augmentation of sertraline with 2 g/d of EPA for 10 weeks did not result in greater improvement in depressive symptoms compared to sertraline and corn oil placebo in patients with major depressive disorder and CHD or CHD risk factors. Identifying the characteristics of cardiac patients whose depression may benefit from omega-3 and clarifying the pathways linking omega-3 to improvement in depression symptoms are important directions for future research. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02021669; FDA IND registration number: 121107.

SUBMITTER: Carney RM

PROVIDER: S-EPMC6550340 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.

Carney Robert M RM Freedland Kenneth E KE Rubin Eugene H EH Rich Michael W MW Steinmeyer Brian C BC Harris William S WS

The Journal of clinical psychiatry 20190604 4

<h4>Objective</h4>Studies of depressed psychiatric patients have suggested that antidepressant efficacy can be increased by adding eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish oils. The purpose of this study was to determine whether the addition of EPA improves the response to sertraline in depressed patients with or at high risk for coronary heart disease (CHD).<h4>Methods</h4>Between May 2014 and June 2018, 144 patients with DSM-5 major depressive disorder seen at ...[more]

PMID: 31163106

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Project description:Background and objectivesDepression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness.Design, setting, participants, & measurementsPatients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ?16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial.ResultsIn total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ?16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (P<0.001), and Montgomery-Asberg Depression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (P<0.001). There were no differences between sertraline and placebo groups.ConclusionsAlthough small, this is the largest randomized trial to date of antidepressant medication in patients on hemodialysis. Our results highlight recruitment issues. No benefit was observed, but trial size and the substantial dropout render consideration of benefit inconclusive. A definitive trial could use shorter follow-up and include depressed patients already taking antidepressants.

Project description:BackgroundSelf-management of lifestyle and cardiovascular disease risk factors is challenging in older patients with coronary heart disease (CHD). SMS text messaging could be a potential support tool for self-management and the most affordable and accessible method through a mobile phone. High-quality evidence had been lacking, and previous studies evaluated the effects of SMS text messaging on the subjective measures of short-term outcomes. Recently, a large-sized randomized controlled trial in Australia reported promising findings on the objective measures upon 6-month follow-up. However, an examination of the effectiveness of such interventions in an Asian population with unique demographic characteristics would be worthwhile.ObjectiveThis study examined the effectiveness of a 1-way SMS text messaging program to modify the lifestyle and cardiovascular disease risk factors of patients who underwent the first percutaneous coronary intervention (PCI).MethodsA parallel, single-blinded, 1:1 random allocation clinical trial was conducted with 879 patients treated through PCI. They were recruited during hospital admission from April 2017 to May 2020 at 2 university hospitals in the Republic of Korea. In addition to standard care, the intervention group received access to a supporting website and 4 SMS text messages per week for 6 months regarding a healthy diet, physical activity, smoking cessation, and cardiovascular health. Random allocation upon study enrollment and SMS text messaging after hospital discharge were performed automatically using a computer program. The coprimary outcomes were low-density-lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and BMI. The secondary outcomes were change in lifestyle and adherence to the recommended health behaviors.ResultsOf the eligible population, 440 and 439 patients who underwent PCI were assigned to the intervention and control groups, respectively. The 1-way SMS text messaging program significantly enhanced physical activity (P=.02), healthy diet (P<.01), and medication adherence (P<.04) among patients with CHD. Hence, more people were likely to control their cardiovascular disease risk factors per the recommendations. The intervention group was more likely to control all 5 risk factors by 62% (relative risk 1.62, 95% CI 1.05-2.50) per the recommendations. On the other hand, physiological measures of the primary outcomes, including LDL-C levels, SBP, and BMI, were not significant. Most participants found the SMS text messaging program useful and helpful in motivating lifestyle changes.ConclusionsLifestyle-focused SMS text messages were effective in the self-management of a healthy diet, exercise, and medication adherence, but their influence on the physiological measures was not significant. One-way SMS text messages can be used as an affordable adjuvant method for lifestyle modification to help prevent the recurrence of cardiovascular disease.Trial registrationClinical Research Information Service (CRiS) KCT0005087; https://cris.nih.go.kr/cris/search/detailSearch.do/19282.

Dataset Information

A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.

Publications

A Randomized Placebo-Controlled Trial of Omega-3 and Sertraline in Depressed Patients With or at Risk for Coronary Heart Disease.

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