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Efficacy of duloxetine on painful physical symptoms in major depressive disorder for patients with clinically significant painful physical symptoms at baseline: a meta-analysis of 11 double-blind, placebo-controlled clinical trials.

ABSTRACT: To review efficacy of duloxetine for physical symptoms and depressive illness in patients with at least mild to moderate major depressive disorder (MDD; DSM-IV) and clinically significant painful physical symptoms at baseline.Global database of duloxetine clinical trials (Eli Lilly and Company).All 11 acute, double-blind, placebo-controlled studies of duloxetine (7 with duloxetine 60-mg doses and 4 with non-60-mg doses) in the database that used a scale to measure painful physical symptoms and were completed before March 17, 2011.For each study, patients with clinically significant pain levels at baseline (Visual Analog Scale overall pain rating ? 30, Numerical Rating Scale score ? 3, or Brief Pain Inventory 24-hour average pain rating ? 3) were selected in order to determine the effect sizes of duloxetine (compared with placebo for each trial) on the pain and depression measures. Overall effect sizes for both painful physical symptoms and MDD were obtained from the mean of individual-trial effect sizes, and each effect size was weighted relative to the number of patients within each study.The overall mean effect sizes were as follows: painful physical symptoms-60-mg trials, 0.29 (95% CI, 0.06 to 0.52); non-60-mg trials, 0.13 (95% CI, -0.19 to 0.45); MDD-60-mg trials, 0.29 (95% CI, 0.18 to 0.40); non-60-mg trials, 0.16 (95% CI, 0.00 to 0.32). Across the 11 studies, the weighted effect size for painful physical symptoms was 0.26 (95% CI, 0.00 to 0.51) and for MDD, 0.25 (95% CI, 0.16 to 0.34).According to this meta-analysis, duloxetine 60 mg once daily is as effective in improving painful physical symptoms as it is for depression in patients with MDD and clinically significant painful physical symptoms. The results of this meta-analysis indicate that duloxetine has small effect sizes in reducing painful physical symptoms and depressive symptoms in patients with MDD and clinically significant pain levels at baseline. Thus, the results of the study permit one to conclude that duloxetine has a clinically significant impact on painful physical symptoms and in reducing the severity of depressive symptoms. However, the results do not address its efficacy compared to other alternatives, as in all studies the comparator was placebo.

SUBMITTER: Ball SG

PROVIDER: S-EPMC3304689 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Efficacy of duloxetine on painful physical symptoms in major depressive disorder for patients with clinically significant painful physical symptoms at baseline: a meta-analysis of 11 double-blind, placebo-controlled clinical trials.

Ball Susan G SG Desaiah Durisala D Spann Melissa E ME Zhang Qi Q Russell James M JM Robinson Michael J MJ Demyttenaere Koen K

The primary care companion for CNS disorders 20110101 6

<h4>Objective</h4>To review efficacy of duloxetine for physical symptoms and depressive illness in patients with at least mild to moderate major depressive disorder (MDD; DSM-IV) and clinically significant painful physical symptoms at baseline.<h4>Data sources</h4>Global database of duloxetine clinical trials (Eli Lilly and Company).<h4>Study selection</h4>All 11 acute, double-blind, placebo-controlled studies of duloxetine (7 with duloxetine 60-mg doses and 4 with non-60-mg doses) in the databa ...[more]

PMID: 22454807

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Project description:The objective of this study was to assess the effectiveness of duloxetine monotherapy, in comparison with selective serotonin reuptake inhibitor (SSRI) monotherapy, in the treatment of painful physical symptoms (PPS) in Japanese patients with major depressive disorder (MDD) in real-world clinical settings.This was a multicenter, 12-week prospective, observational study. This study enrolled MDD patients with at least moderate PPS, defined as a Brief Pain Inventory-Short Form (BPI-SF) average pain score (item 5) ≥3. Patients were treated with duloxetine or SSRIs (escitalopram, sertraline, paroxetine, or fluvoxamine) for 12 weeks, and PPS were assessed by BPI-SF average pain score. The primary outcome was early improvement in the BPI-SF average pain score at 4 weeks post-baseline.A total of 523 patients were evaluated for treatment effectiveness (duloxetine N=273, SSRIs N=250). The difference in BPI-SF average pain score between the two groups was not statistically significant at 4 weeks post-baseline, the primary endpoint (least-squares mean change from baseline [95% confidence interval]: duloxetine, -2.8 [-3.1, -2.6]; SSRIs, -2.5 [-2.8, -2.3]; P=0.166). There was a numerical advantage for duloxetine in improvement from 4 to 12 weeks post-baseline, and the difference was statistically significant at 8 weeks post-baseline (least-squares mean change from baseline [95% confidence interval]: duloxetine, -3.6 [-3.9, -3.3]; SSRIs, -3.1 [-3.4, -2.8]; P=0.023). The 30% and 50% responder rates were significantly higher in patients treated with duloxetine at 4 and 8 weeks post-baseline. There were no serious adverse events experienced by duloxetine-treated patients. The rate of discontinuations due to adverse events was similar for duloxetine and the SSRIs (1.0% and 0.8% of patients, respectively).In this observational study, BPI-SF improvement was not significantly different at 4 weeks, the primary endpoint; however, patients treated with duloxetine tended to show better improvement in PPS compared to those treated with SSRIs.

Project description:In hospital settings, depression is an underdetected, undertreated, but prevalent and interfering illness that is associated with significant disability, morbidity, and mortality. A general hospital emergency department (ED) setting may be well suited to identify individuals with clinically significant depressive symptoms, facilitating their referral and treatment.Cross-sectional data of adult ED patients in a general hospital enrolling in a human immunodeficiency virus (HIV) screening study between February 2007 and March 2008 were analyzed. Data included demographic factors, the Center for Epidemiologic Studies Depression Scale (CES-D), alcohol and substance use history, sexual risk taking, and brief medical history. The primary outcome was a dichotomous measure of self-reported clinically significant depressive symptoms. Patients who scored >/= 16 on the CES-D were considered to screen positive for depressive symptoms.Of the 3,262 patients enrolled in the screening trial, 2,588 (79%) completed the survey between February 2007 and March 2008. Among these, 1,945 (75%) completed the psychosocial assessment battery; 596 (31%) survey completers screened positive for clinically significant depressive symptoms. In a multivariable model, female sex (RR = 1.36; 95% CI, 1.16-1.57), being unemployed (RR = 1.61; 95% CI, 1.32-1.93), and lower annual income (RR from 1.73 to 2.24) were associated with increased rates of clinically significant depressive symptoms (CES-D score >/= 16). Clinically significant depressive symptoms were more often present in patients who screened positive for alcohol dependence (RR = 1.48; 95% CI, 1.19-1.78), individuals reporting current smoking (RR = 1.39; 95% CI, 1.17-1.62), those with a prior psychiatric disorder diagnosis (RR = 2.20; 95% CI, 1.80-2.57) or history of hypertension (RR = 1.47; 95% CI, 1.18-1.79), and those who reported ever having sex with an HIV-infected partner (RR = 1.58; 95% CI, 1.08-2.09).This study identified a high frequency of undiagnosed clinically significant depressive symptoms among ED patients and highlights several new demographic and clinical correlates of such symptoms. Screening for and diagnosis of clinical depression in the ED setting introduces important opportunities for acute care providers and for the health care system as a whole.

Project description:BackgroundVariation in family therapeutic intervention fidelity has an impact on outcomes. The use of video conferencing technology can strengthen therapist fidelity to family therapeutic interventions.ObjectiveThis article explores indicators of feasibility and acceptability for a video-delivered family therapeutic intervention for perinatal women with depressive symptoms and family conflict. The objectives of this article are to describe indicators of feasibility, including therapist fidelity to the intervention and technological factors that relate to implementation of the intervention, as well as indicators of acceptability for participants of the intervention.MethodsThe data included in this article are from an ongoing randomized trial of the Resilience Enhancement Skills Training (REST) video-delivered family therapeutic intervention. Participant recruitment and data collection are still underway for this clinical trial. Of the 106 participants who are currently enrolled in this study, 54 (51%) have been randomized to receive REST from May 2021 through July 2022. Currently, 2 therapists are delivering the intervention, and the training procedures for therapists are summarized herein. Therapist fidelity to the family therapeutic intervention was assessed in 67 audio recorded sessions. The training procedures were summarized for use of video conferencing technology by therapists and the 54 study participants. Knowledge of the video conferencing technology features was assessed in therapists and study participants by the number of attempts required to use the features. Participant responsiveness to the intervention was assessed by the percentage of attended sessions and percentage of complete homework assignments.ResultsTo date, both therapists have demonstrated high fidelity to the family therapeutic intervention and used all video conferencing technology features on their first attempt. The current participants required 1 to 3 attempts to use 1 or more of the video conferencing technology features. About 59% (n=32) of the current participants immediately accessed the features on the first attempt. Our results show that perinatal women attended all sessions, and their family members attended 80% of the sessions. To date, participants have completed 80% of the homework assignments.ConclusionsThese early findings describe indicators of the feasibility and acceptability of the video-delivered family therapeutic intervention for use with this high priority population. Upon completion of recruitment and data collection, a subsequent article will include a mixed methods process evaluation of the feasibility and acceptability of the video-delivered family therapeutic intervention.Trial registrationClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776.

Project description:ImportanceCardiovascular health may be used for prevention of depressive symptoms. However, data on the association of cardiovascular health across midlife with depressive symptoms are lacking.ObjectiveTo evaluate whether better baseline cardiovascular health and improvement of cardiovascular health over time are associated with a lower risk of both incident depressive symptoms and unfavorable trajectories of depressive symptoms.Design, setting, and participantsParticipants without depressive symptoms were included from a prospective community-based cohort in France (GAZEL cohort). Cardiovascular health examinations occurred in 1990 and 1997 and assessment of depressive symptoms in 1997 and every 3 years thereafter until 2015. Data were analyzed from January to October 2022.ExposuresNumber of cardiovascular health metrics (smoking, body mass index, physical activity, diet, blood pressure, glucose, and cholesterol) at an intermediate or ideal level in 1997 (range, 0-7) and 7-year change in cardiovascular health between 1990 and 1997.Main outcomes and measuresPrimary outcome was incident depressive symptoms (20-item Center for Epidemiologic Studies-Depression Scale [CES-D] score of 17 or greater in men or 23 or greater in women); secondary outcome was trajectories of depressive symptoms scores. Trajectories included consistently low scores, moderately elevated scores, low starting then increasing scores, moderately high starting, increasing, then remitting scores, and moderately high starting then increasing scores.ResultsOf 6980 included patients, 1671 (23.9%) were women, and the mean (SD) age was 53.3 (3.5) years. During a follow-up spanning 19 years after 1997, 1858 individuals (26.5%) had incident depressive symptoms. Higher baseline cardiovascular health in 1997 and improvement in cardiovascular health over 7 years were each associated with lower risk of depressive symptoms (odds ratio [OR] per additional metric at intermediate or ideal level at baseline, 0.87; 95% CI, 0.84-0.91; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.91; 95% CI, 0.86-0.96). Also, better cardiovascular health was associated with lower risk of unfavorable depressive symptoms trajectories. Compared with the consistently low score trajectory, the lowest risks were observed for the low starting then increasing score trajectory (OR per additional metric at intermediate or ideal level at baseline, 0.70; 95% CI, 0.64-0.76; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.73; 95% CI, 0.68-0.79) and the moderately high starting then increasing score trajectory (OR per additional metric at intermediate or ideal level at baseline, 0.71; 95% CI, 0.64-0.79; OR per 1 higher metric at intermediate or ideal level over 7 years, 0.71; 95% CI, 0.64-0.77).Conclusions and relevanceIn this prospective community-based cohort study of adults, higher cardiovascular health was associated with a lower risk of depressive symptoms over time. Elucidating which set of cardiovascular factors may affect depression risk could be important for prevention.

Dataset Information

Efficacy of duloxetine on painful physical symptoms in major depressive disorder for patients with clinically significant painful physical symptoms at baseline: a meta-analysis of 11 double-blind, placebo-controlled clinical trials.

Publications

Efficacy of duloxetine on painful physical symptoms in major depressive disorder for patients with clinically significant painful physical symptoms at baseline: a meta-analysis of 11 double-blind, placebo-controlled clinical trials.

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