scholarly journals The Efficacy, Safety, and Tolerability of Probiotics on Depression: Clinical Results From an Open-Label Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Caroline J. K. Wallace ◽  
Roumen V. Milev
Keyword(s):  
Pilot Study ◽  
Clinical Symptoms ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bifidobacterium Longum ◽  
Lactobacillus Helveticus ◽  
Self Report ◽  
Open Label ◽  
Symptoms Of Depression ◽  
Treatment Naïve

Background: A growing body of research has shown that consumption of probiotics can improve symptoms associated with mood and anxiety disorders through activity of the gut-brain axis. However, the effects of probiotics have yet to be tested in a clinical sample of treatment-naïve patients diagnosed with Major Depressive Disorder (MDD). The aim of this 8-week, open-label pilot study is to examine changes in depressive symptoms before and after the introduction of a probiotic supplement in 10 treatment-naïve MDD patients and to provide data on the feasibility of conducting a larger double-blind, randomized, placebo-controlled trial in the same patient population. Here we report on the clinical outcome measures of the study.Methods: Participants recruited from the community in Kingston, Ontario, Canada consumed a probiotic supplement containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (CEREBIOME®) at a dose of 3 × 109 CFU once per day for 8 weeks. Clinical symptoms of depression were measured using a validated battery of clinical scales and self-report questionnaires (CAN-BIND protocol). Data was collected at baseline, week 4, and week 8.Results: Significant improvements in affective clinical symptoms were observed at week 4 and were sustained at week 8. Significant improvements in subjective sleep quality were observed by week 8. No side effects or adverse effects associated with the probiotic supplement were observed.Conclusions: The findings from this study support the existing evidence in this emerging field for probiotics having a role in alleviating symptoms of depression in treatment-naïve, moderately depressed patients and indicate that the probiotic supplement is safe and well-tolerated in this population. However, further comprehensive studies are required to draw conclusions.

scholarly journals Associations between Trauma, Dissociation, Adult Attachment and Proneness to Hallucinations

2017 ◽  
Vol 46 (3) ◽  
pp. 292-301 ◽  
Author(s):  
Katherine Berry ◽  
Paul Fleming ◽  
Samantha Wong ◽  
Sandra Bucci
Keyword(s):  
Negative Affect ◽  
Adult Attachment ◽  
Clinical Symptoms ◽  
Clinical Sample ◽  
Childhood Adversity ◽  
Self Report ◽  
Clinical Population ◽  
Clinical Samples ◽  
Childhood Trauma Questionnaire ◽  
Relative Contribution

Background: Childhood adversity, dissociation and adult attachment have all been implicated in the development of hallucinations or ‘voice-hearing’. Testing psychological models in relation to subclinical phenomena, such as proneness to hallucinations in non-clinical samples, provides a convenient methodology to develop understanding of the processes and mechanisms underlying clinical symptoms. Aims: This paper investigates the relative contribution of childhood adversity, dissociation and adult attachment in explaining hallucination proneness in a non-clinical sample. Methods: Students and staff with no previous contact with secondary care at the University of Manchester were recruited. Participants completed a series of self-report measures: the Launay‒Slade Hallucination Scale (LSHS), the Relationship Scale Questionnaire (RSQ), the Childhood Trauma Questionnaire (CTQ), the Dissociative Experiences Schedule (DES II) and the Positive and Negative Affect Schedule (PANAS). Results: As hypothesized, insecure attachment, childhood adversity and dissociative symptoms were correlated with hallucination proneness. Multiple regression analysis, controlling for confounds of age and negative affect, indicated that the RSQ, CTQ and DES II predicted hallucination proneness. Only DES II and RSQ avoidant attachment were significant independent predictors in the final model. Conclusions: This study provides further evidence to support the idea that attachment and dissociation are important psychological mechanisms involved in voice-hearing proneness. Further testing is required with a clinical population.

scholarly journals A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
D. E. Patton ◽  
J. J. Francis ◽  
E. Clark ◽  
F. Smith ◽  
C. A. Cadogan ◽  
...  
Keyword(s):  
Pilot Study ◽  
Process Evaluation ◽  
Behaviour Change ◽  
Older Patients ◽  
Controlled Trial ◽  
Theoretical Domains Framework ◽  
Self Report ◽  
Community Pharmacies ◽  
Behaviour Change Techniques ◽  
Limited Effectiveness

Abstract Background Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. Methods As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Discussion Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures. Trial registration This study is registered at ISRCTN: 10.1186/ISRCTN73831533

scholarly journals Spousal resemblance in psychopathology: A comparison of parents of children with and without psychopathology

2016 ◽  
Vol 34 ◽  
pp. 49-55 ◽  
Author(s):  
LW Wesseldijk ◽  
GC Dieleman ◽  
RJL Lindauer ◽  
M Bartels ◽  
G Willemsen ◽  
...  
Keyword(s):  
Psychiatric Symptoms ◽  
Clinical Sample ◽  
Population Based ◽  
Self Report ◽  
Antisocial Personality ◽  
Externalizing Psychopathology ◽  
Symptoms Of Depression ◽  
Symptom Domains ◽  
Symptom Scores ◽  
Internalizing And Externalizing

AbstractBackgroundSpouses resemble each other for psychopathology, but data regarding spousal resemblance in externalizing psychopathology, and data regarding spousal resemblance across different syndromes (e.g. anxiety in wives and attention deficit/hyperactivity disorder [ADHD] in husbands) are limited. Moreover, knowledge is lacking regarding spousal resemblance in parents of children with psychiatric disorders. We investigated and compared spousal resemblance within and across internalizing and externalizing symptom domains in parents of children with and without psychopathology.MethodsSymptoms of depression, anxiety, avoidant personality, ADHD, and antisocial personality were assessed with the Adult Self Report in 728 mothers and 544 fathers of 778 children seen in child and adolescent psychiatric outpatient clinics and in 2075 mothers and 1623 fathers of 2784 children from a population-based sample. Differences in symptom scores and spousal correlations between the samples were tested.ResultsParents in the clinical sample had higher symptom scores than in the population-based sample. In both samples, correlations within and across internalizing and externalizing domains of psychopathology were significant. Importantly, correlations were significantly higher in the clinical sample (P = 0.03). Correlations, within and across symptoms, ranged from 0.14 to 0.30 in the clinical sample and from 0.05 to 0.23 in the population-based sample.ConclusionsThis large study shows that spousal resemblance is not only present within but also across symptom domains. Especially in the clinical sample, ADHD symptoms in fathers and antisocial personality symptoms in mothers were correlated with a range of psychiatric symptoms in their spouses. Clinicians need to be alert of these multiple affected families.

scholarly journals Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
R. Casañas ◽  
R. Catalán ◽  
R. Penadés ◽  
J. Real ◽  
S. Valero ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Antidepressant Medication ◽  
Psychoeducational Intervention ◽  
Control Group ◽  
Intention To Treat ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Treatment Naïve

Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention.Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis.Results. The PE program group showed remission of symptoms of 40% (P=0.001) posttreatment and 42% (P=0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’sd′=0.55).Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

scholarly journals CASSETTE - clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Ravindra Dotel ◽  
Steven YC Tong ◽  
Asha Bowen ◽  
Jane N Nelson ◽  
Matthew VN O'Sullivan ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Methicillin Resistance ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Protein Synthesis Inhibitor ◽  
Open Label ◽  
Randomised Controlled

Abstract Background: Exotoxins are an important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this is lacking. Methods: An open label, multicenter, randomised controlled trial (RCT) will compare outcome differences in severe S. aureus infection between a standard treatment (flucloxacillin/cefazolin in methicillin-susceptible S. aureus; and vancomycin/daptomycin in methicillin-resistance S. aureus) and a standard treatment plus an additional clindamycin given for 7 days. We will include a minimum of 60 participants (both adult and children) in the pilot study. Participants will be enrolled within 72 hours of an index culture. Severe infections will include septic shock, necrotising pneumonia, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Immunosuppressed, moribund, current severe diarrhea or C. difficile infection, pregnant, and those with anaphylaxis to beta-lactams or lincosamides will be excluded. Primary outcomes measure is number of days alive and free (1 or none) of SIRS (Systemic Inflammatory Response Syndrome) within the first 14 days post randomization. Secondary outcomes measure will include all-cause mortality at 14, 42 and 90 days, time to resolution of SIRS, proportion with microbiological treatment failure, and rate of change of C-reactive protein over time. Impacts of inducible clindamycin resistance, strains types, methicillin-susceptibility, and presence of various exotoxins will also be analysed. Discussion: This study will assess the effect of adjunctive clindamycin on patient-centered outcomes in severe, toxin mediated S. aureus infections. The Pilot study will provide feasibility for a much larger RCT. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12617001416381p. Registered 06 October 2017 Keywords: Staphylococcus aureus, exotoxins, prospective studies, clindamycin, leukocidins

scholarly journals Pragmatic randomised controlled trial of very early etanercept and MTX versus MTX with delayed etanercept in RA: the VEDERA trial

2020 ◽  
Vol 79 (4) ◽  
pp. 464-471 ◽  
Author(s):  
Paul Emery ◽  
Sarah Horton ◽  
Raluca Bianca Dumitru ◽  
Kamran Naraghi ◽  
Désirée van der Heijde ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Power Doppler ◽  
Treat To Target ◽  
Symptom Duration ◽  
First Line ◽  
Open Label ◽  
Remission Rates ◽  
Treatment Naïve ◽  
Randomised Controlled

ObjectivesWe sought to confirm in very early rheumatoid arthritis (ERA) a much greater superiority (30%) of first-line etanercept+methotrexate (ETN+MTX) over treat-to-target MTX (MTX-TT) than previously reported in ERA (14%); and explore whether ETN following initial MTX secures a comparable response to first-line ETN+MTX.MethodsPragmatic, open-label, randomised controlled trial of treatment-naïve ERA (≤12 months symptom), Disease Activity Score 28 joint (DAS28)-erythrocyte sedimentation rate (ESR) ≥3.2, rheumatoid factor (RF)+/−anticitrullinated peptide antibody (ACPA) positive or ultrasound power Doppler (PD) if RF and ACPA negative. Subjects were randomised 1:1 to ETN+MTX; or MTX-TT, escalated to ETN if week 24 DAS28-ESR ≥2.6 and intramuscular corticosteroid at protocolised time points. Primary endpoint of week 48 DAS28ESR remission with clinical and imaging secondary endpoints.ResultsWe randomised 120 patients, 60 to each arm (71% female, 73% RF/84% ACPA positive, median (IQR) symptom duration 20.3 (13.1, 30.8) weeks; mean (SD) DAS28 5.1 (1.1)). Remission rates with ETN+MTX and MTX-TT, respectively, were 38% vs 33% at week 24; 52% vs 38% at week 48 (ORs 1.6, 95% CI 0.8 to 3.5, p=0.211). Greater, sustained DAS28-ESR remission observed with ETN+MTX versus MTX-TT (42% and 27%, respectively; p=0.035). PD was fully suppressed by week 48 in over 90% in each arm. Planned exploratory analysis revealed OR 2.84, 95% CI 0.8 to 9.6) of achieving remission after 24 weeks of ETN administered first line compared with administered post-MTX.ConclusionsCompared with remission rates typically reported with first-line tumour necrosis factor inhabitor+MTX versus MTX-TT, we did not demonstrate a larger effect in very ERA. Neither strategy conferred remission in the majority of patients although ultrasound confirmed local inflammation suppression. Poorer ETN response following failure of MTX-TT is also suggested.Trial registration numberNCT02433184

A phase II, open label, randomized controlled trial of nivolumab plus ipilimumab with stereotactic radiotherapy versus ipilimumab plus nivolumab alone in patients with melanoma brain metastases (ABC-X Trial).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS9600-TPS9600 ◽  
Author(s):  
Maria Gonzalez ◽  
Angela M. Hong ◽  
Matteo S. Carlino ◽  
Victoria Atkinson ◽  
Wei Wang ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Stereotactic Radiotherapy ◽  
Controlled Trial ◽  
Tumour Response ◽  
Previous Treatment ◽  
Open Label ◽  
Absolute Increase ◽  
Significance Level ◽  
Melanoma Brain Metastases ◽  
Treatment Naïve

TPS9600 Background: Nivolumab combined with ipilimumab is active in melanoma brain metastases, with intracranial response rates > 55% and durable survival in treatment naïve patients (pts) (Long GV et al Lancet Onc 2018; Tawbi H et al NEJM 2018). We seek to determine if the addition of stereotactic radiotherapy (SRS) results in improved intracranial outcomes. Methods: This is a multisite, open-label, phase 2 trial in systemic treatment-naïve pts with melanoma brain metastases. Pts must have ≥1 asymptomatic brain metastases that are ≥5mm and ≤40mm as per modified RECIST 1.1, on gadolinium-enhanced MRI, and no history of previous treatment with SRS. Eligible pts are randomly assigned to either receive nivolumab plus ipilimumab with SRS or nivolumab plus ipilimumab alone. Nivolumab (1mg/kg) and ipilimumab (3mg/kg) are given every 3 weeks for 4 doses. Following induction, 480mg nivolumab is given every 4 weeks until progression, unacceptable toxicity, or a maximum of 2 years. SRS is administered as single fraction of 16-22Gy, or hypofractionated for larger lesions (24-27Gy in 3 fractions), within 7 days of immunotherapy commencement. Pts will be evaluated for intracranial and extracranial tumour response, and overall response, every 6 weeks to week 24 and 12 weekly thereafter until overall disease progression or death. The primary endpoint is neurologic specific survival (NSS) at 12 months. Secondary endpoints include intracranial response rate, intracranial PFS, overall PFS, overall progression free survival, overall survival, neurocognitive function and incidence of radiation necrosis. 109 patients in each cohort (218 total) will achieve > 80% power at the significance level (alpha) of 0.10 to detect a minimum absolute increase of 9% in the NSS rate at 12 months. Clinical trial information: NCT03340129.

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