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S-Adenosylmethionine (SAMe) monotherapy for depression: an 8-week double-blind, randomised, controlled trial.
Sarris, J, Murphy, J, Stough, C, Mischoulon, D, Bousman, C, MacDonald, P, Adams, L, Nazareth, S, Oliver, G, Cribb, L, et al
Psychopharmacology. 2020;(1):209-218
Abstract
RATIONALE Dysregulation of the one carbon cycle is documented in depression. Thereby, S-adenosylmethionine (SAMe), a one-carbon cycle nutraceutical compound with a favourable side effect profile, has a theoretical rationale for efficacy. However, further controlled studies are required to confirm SAMe's efficacy. OBJECTIVES To test the efficacy of SAMe versus placebo in unmedicated DSM-5 diagnosed (major depressive disorder) (MDD) patients with mild-to-moderate levels of depressive symptoms. METHODS We conducted an 8-week, double-blind, randomised controlled trial testing 800 mg/day of SAMe monotherapy versus placebo in 49 patients with MDD (Montgomery-Åsberg Depression Rating Scale [MADRS] score 14-25) who were not currently taking antidepressants. One-carbon cycle biomarkers, brain-derived neurotropic factor (BDNF), and relevant single nucleotide polymorphisms (SNPs) were analysed as potential treatment moderators. RESULTS A clinically relevant differential reduction from baseline to week 8 of 3.76 points occurred on the primary outcome (MADRS) in favour of SAMe. This however was not significant (p = 0.13) on an adjusted linear mixed model, notwithstanding a medium to large effect size of 0.72. A high placebo response rate of 53% occurred (> 50% reduction on MADRS). Exploratory analyses showed that SAMe was however effective in reducing depression amongst participants with milder depression severity (MADRS ≤ 22, p = 0.045). Response was not moderated by BDNF, SNPs, or one-carbon cycle biomarkers, although increased folate concentrations were correlated with improved symptoms in the SAMe group (r = - 0.57, p = 0.026). The treatment was safe and well tolerated. CONCLUSIONS Although a differential reduction in depression symptoms between groups was observed in favour of SAMe, the results of this pilot study were not statistically significant. TRIAL REGISTRATION ANZCTR-Australian New Zealand Clinical Trials Registry; No.: ACTRN12613001299796; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364900.
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Smoking, drinking, and depression: comorbidity in head and neck cancer patients undergoing radiotherapy.
McCarter, K, Baker, AL, Britton, B, Wolfenden, L, Wratten, C, Bauer, J, Halpin, SA, Carter, G, Beck, AK, Leigh, L, et al
Cancer medicine. 2018;(6):2382-2390
Abstract
We aimed to determine the prevalence and co-occurrence of tobacco smoking, alcohol consumption, and depressive symptoms among a sample of head and neck cancer (HNC) patients undergoing radiotherapy. A total of 307 HNC patients participated in a multi-site stepped-wedge randomized controlled trial (RCT) evaluating the effectiveness of a dietitian-delivered health behavior intervention in patients with HNC undergoing radiotherapy. During week one of radiotherapy patients completed measures of smoking, alcohol consumption, and level of depression. Approximately one-fifth (21%) of patients had two or more co-occurring problems: current smoking, hazardous alcohol use, and/or likely presence of a major depressive episode (MDE). Approximately one-third (34%) of the sample were current smokers, one-third (31%) were drinking hazardously and almost one-fifth (19%) had likely cases of depression. Comorbidity of smoking, hazardous alcohol use, and MDE is high in HNC patients, and interventions need to address this cluster of cancer risk factors.
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Functional Reach, Depression Scores, and Number of Medications Are Associated With Number of Falls in People With Chronic Stroke.
Alenazi, AM, Alshehri, MM, Alothman, S, Rucker, J, Dunning, K, D'Silva, LJ, Kluding, PM
PM & R : the journal of injury, function, and rehabilitation. 2018;(8):806-816
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BACKGROUND Falls are a common adverse event among people with stroke. Previous studies investigating risk of falls after stroke have relied primarily on retrospective fall history ranging from 6-12 months recall, with inconsistent findings. OBJECTIVES To identify factors and balance assessment tools that are associated with number of falls in individuals with chronic stroke. DESIGN Secondary analysis of a randomized clinical trial. SETTING Multisite academic and clinical institutions. PARTICIPANTS Data from 181 participants with stroke (age 60.67 ± 11.77 years, post stroke 4.51 ± 4.78 years) were included. METHODS Study participants completed baseline testing and were prospectively asked about falls. A multivariate negative binomial regression was used to identify baseline predictive factors predicting falls: age, endurance (6 minute walk test), number of medications, motor control (Fugl-Meyer lower extremity score), depression (Patient Health Questionnaire-9), physical activity (number of steps per week), and cognition (Mini Mental Status Exam score). A second negative binomial regression analysis was used to identify baseline balance assessment scores predicting falls: gait velocity (comfortable 10 Meter Walk), Berg Balance Scale (BBS), Timed Up and Go (TUG), and Functional Reach Test (FRT). Receiver operating characteristic (ROC) and area under the curve (AUC) were used to determine the cutoff scores for significant predictors of recurrent falls. MAIN OUTCOME MEASUREMENT The number of falls during the 42-week follow-up period. RESULTS Baseline measures that significantly predicted the number of falls included increased number of medications, higher depression scores, and decreased FRT. Cutoff scores for the number of medications were 8.5 with an AUC of 0.68. Depression scores differentiated recurrent fallers at a threshold of 2.5 scores with an AUC of 0.62. FRT differentiated recurrent fallers at a threshold of 18.15 cm with an AUC of 0.66. CONCLUSIONS Number of medications, depression scores, and decreased FRT distance at baseline were associated with increased number of falls. Increased medications might indicate multiple comorbidities or polypharmacy effect; increased depression scores may indicate psychological status; and decreased functional reach distance could indicate dynamic balance impairments. LEVEL OF EVIDENCE II.
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Age Modifies the Association Between Depressive Symptoms and Adherence to Self-Testing With Telemedicine in Patients With Inflammatory Bowel Disease.
Chudy-Onwugaje, K, Abutaleb, A, Buchwald, A, Langenberg, P, Regueiro, M, Schwartz, DA, Tracy, JK, Ghazi, L, Patil, SA, Quezada, S, et al
Inflammatory bowel diseases. 2018;(12):2648-2654
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BACKGROUND Depression is common in patients with inflammatory bowel disease (IBD) and is known to be associated with poor adherence in the usual care setting. In the last decade, there has been an increase in the use of information technology (IT) for the delivery of IBD care, but the association between depressive symptoms (DS) and adherence to self-testing in this context is not known. We aimed to investigate this association among IBD patients managed via a text messaging-based telemedicine system. METHODS This was a prospective study of participants in the 2 intervention arms of the Telemedicine for Patients with IBD (TELE-IBD) trial. Depressive symptoms were measured at baseline, and then participants received periodic text messages to initiate IBD-specific self-testing. Treatment plans were similarly conveyed, and adherence to self-testing was evaluated at the end of 1 year. Regression analyses were performed, and age-stratified models were constructed to evaluate for effect modification. RESULTS Of the 193 study participants, 48% had DS at baseline. Overall, there was no significant association between DS and adherence to self-testing. However, upon stratification by age, adherence increased with depressive symptoms in those that were 40 years and younger (P = 0.02), but there was no association between depressive symptoms and adherence in the older group (P = 0.53). CONCLUSIONS Younger IBD patients with DS have high adherence when managed in a text messaging-based telemedicine program. Telemedicine interventions have the potential to improve health outcomes in this demographic-a group that is often thought to be difficult to manage due to nonadherence.
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Depression and Anxiety: Lack of Associations with an Inadequate Diet in a Sample of Pregnant Women with a History of Bariatric Surgery-a Multicenter Prospective Controlled Cohort Study.
Jans, G, Matthys, C, Bogaerts, A, Ameye, L, Delaere, F, Roelens, K, Loccufier, A, Logghe, H, De Becker, B, Verhaeghe, J, et al
Obesity surgery. 2018;(6):1629-1635
Abstract
BACKGROUND Anxiety and depression levels are higher in obese compared to those in normal weight pregnant women. The aims of this study are to examine anxiety and depression in pregnancy following bariatric surgery and to compare with obese pregnant controls considering the dietary intake of polyunsaturated fatty acids (PUFA), folate, and vitamin B12. METHODS Anxiety (State-Trait Anxiety Inventory) and depression (Edinburgh Postnatal Depression Scale) were examined in the first (T1) and third (T3) pregnancy trimester in 54 women with bariatric surgery and 25 obese. T1 and T3 dietary intake of PUFA, folate, and vitamin B12 intake was assessed using a 3-day food record. Mixed models with a compound symmetry covariance structure and regression models were applied. RESULTS About half of the women with surgery had high state and trait anxiety scores (≥ 40), which did not significantly change during pregnancy. Every 10-kg postoperative weight loss was associated with an increase in T1 state and trait anxiety with respectively 2.7 and 2.3 points. A smoking woman had a 8.6-point higher state anxiety score than a non-smoking woman in T1. In T3, every additional hour of sleep was associated with a decrease in trait anxiety score with 1.59 points. Anxiety and depression scores were not associated with and could not be explained by inadequate PUFAs, folate, and vitamin B12 intakes. Anxiety scores were higher following surgery than those in untreated obesity at both time points. CONCLUSION Pregnancy following bariatric surgery induces high levels of anxiety that are not associated with an inadequate maternal diet.
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Diabetic complications do not hamper improvement of health-related quality of life over the course of treatment of diabetic foot ulcers - the Eurodiale study.
Siersma, V, Thorsen, H, Holstein, PE, Kars, M, Apelqvist, J, Jude, EB, Piaggesi, A, Bakker, K, Edmonds, M, Jirkovská, A, et al
Journal of diabetes and its complications. 2017;(7):1145-1151
Abstract
AIMS: Diabetic complications, and in particular diabetic foot ulcers (DFUs), are associated with low health-related quality of life (HRQoL). We evaluated whether the presence of diabetic complications also influenced the improvement of HRQoL during DFU treatment. METHODS 1088 patients presenting for DFU treatment at the centers participating in the Eurodiale study were followed prospectively up to one year. HRQoL was measured both at presentation and after healing or at end of follow up, using EQ-5D: a standardized instrument consisting of five domains and a summary index. The influence of diabetic comorbidity on the course of HRQoL was evaluated for each of the EQ-5D outcomes in multi-level linear regression analyses, adjusting for baseline characteristics. RESULTS HRQoL improved in all EQ-5D outcomes over the course of treatment for those DFUs that healed. The few significant differences in the development of HRQoL between patients with and without comorbidity showed a more beneficial development for patients with comorbidity in DFUs that did not heal or healed slowly. CONCLUSIONS Comorbidity does not hamper improvement of HRQoL in DFU treatment. On the contrary, HRQoL improved sometimes more in patients with certain comorbidity with hard-to-heal ulcers.
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Interactions Between Depression and Lower Urinary Tract Symptoms: The Role of Adverse Life Events and Inflammatory Mechanisms. Results From the European Male Ageing Study.
Castellini, G, Wu, FC, Finn, JD, OʼNeill, TW, Lean, ME, Pendleton, N, Rastrelli, G, Rutter, MK, Gacci, M, Ricca, V, et al
Psychosomatic medicine. 2016;(6):758-69
Abstract
OBJECTIVES Depression and lower urinary tract symptoms (LUTSs) have been found to co-occur among aging men. The present study attempted to clarify the nature of this relationship, considering adverse life events as potential moderators and the inflammation as an underlying biological mechanism. METHODS The relationship between depression and LUTS was evaluated using data from the European Male Ageing Study, the largest multicenter population-based study of aging in European men. The sample included 3369 men who were assessed by means of several self-reported questionnaires, including the Beck Depression Inventory-II, the International Prostate Symptom Score, and the Adverse Life Events Scale. Participants were asked to provide information regarding general health and life-style, and medical comorbidities. Biological measures including prostate-specific antigen, testosterone, and C-reactive protein were measured. RESULTS LUTS and depressive symptoms were correlated (R = 0.32, β = .10, p < .001), even after adjusting for life-style, psychological, and medical variables. A history of adverse life events was associated with both higher LUTS and Beck Depression Inventory scores. Furthermore, adverse life events moderated the LUTS-depression association (F = 22.62, b = 0.061, p < .001), which increased as a function of the number of life events. C-reactive protein was found to mediate the LUTS-depression association. This mediation effect was moderated by number of adverse life events. CONCLUSIONS Participants with a history of adverse life events represent a vulnerable population in whom the association between somatic and depressive symptoms is stronger. One of the biological mechanisms underlying this association could be an activation of the central inflammatory signaling pathways.
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Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression.
Keerthy, D, Youk, A, Srinath, AI, Malas, N, Bujoreanu, S, Bousvaros, A, Keljo, D, DeMaso, DR, Szigethy, EM
Journal of pediatric gastroenterology and nutrition. 2016;(6):658-664
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OBJECTIVES Pediatric patients with inflammatory bowel disease (IBD) are at an increased risk of developing depression compared with community controls. Depression often negatively influences illness behaviors such as resource utilization. We sought to investigate the effects of treating depression on utilization of medical resources in depressed pediatric patients with IBD by comparing rates of health care utilization 1 year before and after psychotherapy. METHOD Two hundred seventeen subjects ages 9 to 17 years with IBD and depression received 3 months of psychotherapy for depression as part of a multicenter randomized controlled trial. Of these 217 subjects, 70 had utilization data available 1 year prior and 1 year after receiving 3 months of psychotherapy. Primary outcomes included frequency of hospitalizations, inpatient hospital days, outpatient gastrointestinal visits, and number of emergency room visits, radiological examinations, and endoscopies. Within subject analyses were completed comparing health care utilization 12 months before psychotherapy compared with the 12 months after the conclusion of psychotherapy. RESULTS Fifty-one and 19 patients had CD and UC, respectively. A total of 55.7% of patients had major depression and 44.3% had minor depression. Overall, all study measures of health care utilization were significantly reduced after psychotherapy (P < 0.01)-including gastrointestinal-related (mean values) hospitalization frequency, inpatient days, outpatient visit, emergency room visits, radiological examinations, and endoscopies. CONCLUSIONS Psychotherapy for comorbid depression in pediatric patients with IBD is associated with decreased GI-related health care utilization. The present study highlights the importance of screening for depression in a pediatric population with IBD, and that psychotherapy may be a reasonable adjunctive treatment for pediatric patients with IBD and comorbid depression.
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Psychosocial factors and obesity in 17 high-, middle- and low-income countries: the Prospective Urban Rural Epidemiologic study.
Rosengren, A, Teo, K, Rangarajan, S, Kabali, C, Khumalo, I, Kutty, VR, Gupta, R, Yusuf, R, Iqbal, R, Ismail, N, et al
International journal of obesity (2005). 2015;(8):1217-23
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BACKGROUND/OBJECTIVES Psychosocial stress has been proposed to contribute to obesity, particularly abdominal, or central obesity, through chronic activation of the neuroendocrine systems. However, these putative relationships are complex and dependent on country and cultural context. We investigated the association between psychosocial factors and general and abdominal obesity in the Prospective Urban Rural Epidemiologic study. SUBJECTS/METHODS This observational, cross-sectional study enrolled 151 966 individuals aged 35-70 years from 628 urban and rural communities in 17 high-, middle- and low-income countries. Data were collected for 125 290 individuals regarding education, anthropometrics, hypertension/diabetes, tobacco/alcohol use, diet and psychosocial factors (self-perceived stress and depression). RESULTS After standardization for age, sex, country income and urban/rural location, the proportion with obesity (body mass index ≥30 kg m(-)(2)) increased from 15.7% in 40 831 individuals with no stress to 20.5% in 7720 individuals with permanent stress, with corresponding proportions for ethnicity- and sex-specific central obesity of 48.6% and 53.5%, respectively (P<0.0001 for both). Associations between stress and hypertension/diabetes tended to be inverse. Estimating the total effect of permanent stress with age, sex, physical activity, education and region as confounders, no relationship between stress and obesity persisted (adjusted prevalence ratio (PR) for obesity 1.04 (95% confidence interval: 0.99-1.10)). There was no relationship between ethnicity- and sex-specific central obesity (adjusted PR 1.00 (0.97-1.02)). Stratification by region yielded inconsistent associations. Depression was weakly but independently linked to obesity (PR 1.08 (1.04-1.12)), and very marginally to abdominal obesity (PR 1.01 (1.00-1.03)). CONCLUSIONS Although individuals with permanent stress tended to be slightly more obese, there was no overall independent effect and no evidence that abdominal obesity or its consequences (hypertension, diabetes) increased with higher levels of stress or depression. This study does not support a causal link between psychosocial factors and abdominal obesity.
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Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial.
Singla, DR, Kumbakumba, E, Aboud, FE
The Lancet. Global health. 2015;(8):e458-e469
Abstract
BACKGROUND Parenting interventions have been implemented to improve the compromised developmental potential among 39% of children younger than 5 years living in low-income and middle-income countries. Maternal wellbeing is important for child development, especially in children younger than 3 years who are vulnerable and dependent on their mothers for nutrition and stimulation. We assessed an integrated, community-based parenting intervention that targeted both child development and maternal wellbeing in rural Uganda. METHODS In this community-based, cluster randomised trial, we assessed the effectiveness of a manualised, parenting intervention in Lira, Uganda. We selected and randomly assigned 12 parishes (1:1) to either parenting intervention or control (inclusion on a waitlist with a brief message on nutrition) groups using a computer-generated list of random numbers. Within each parish, we selected two to three eligible communities that had a parish office or a primary school in which a preschool could be established, more than 75 households with children younger than 6 years, and at least 15 socially disadvantaged families (ie, maternal education of primary school level or lower) with at least one child younger than 36 months. Participants within communities were mother-child dyads, where the child was 12-36 months of age at enrollment, and the mother had low maternal education. In the parenting intervention group, participants attended 12 fortnightly peer-led group sessions focusing on child care and maternal wellbeing. The primary outcomes were cognitive and receptive language development, as measured with the Bayley Scales of Infant Development, 3rd edn. Secondary outcomes included self-reported maternal depressive symptoms, using the Center for Epidemiologic Studies Depression Scale, and child growth. Theoretically-relevant parenting practices, including the Home Observation for Measurement of the Environment inventory, and mother-care variables, such as perceived spousal support, were also assessed as potential mediators. Baseline assessments were done in January, 2013, and endline assessments were done in November, 2013, 3 months after completion of the programme. Ethics approval was received from Mbarara and McGill universities. This trial is registered with ClinicalTrials.gov, NCT01906606. FINDINGS Between December, 2012, and January, 2013, 13 communities (194 dyads) were randomly assigned to receive intervention, and 12 communities (154 dyads) were assigned to a waitlist control. 319 dyads completed baseline measures (171 in the intervention group and 148 in the control group), and 291 dyads completed endline measures (160 in the intervention group and 131 in the control group). At endline, children in the intervention group had significantly higher cognitive scores (58·90 vs 55·65, effect size 0·36, 95% CI 0·12-0·59) and receptive language scores (23·86 vs 22·40, 0·27, 0·03-0·50) than did children in the control group. Mothers in the intervention group reported significantly fewer depressive symptoms (15·36 vs 18·61, -0·391, 95% CI -0·62 to -0·16) than did mothers in the control group. However, no differences were found in child growth between groups. INTERPRETATION The 12 session integrated parenting intervention delivered by non-professional community members improved child development and maternal wellbeing in rural Uganda. Because this intervention was largely managed and implemented by a local organisation, using local community members and minimal resources, such a programme has the potential to be replicated and scaled up in other low-resource, village-based settings. FUNDING Plan Uganda via Plan Finland (Ministry of Foreign Affairs) and Plan Australia (Australian Aid).