scholarly journals Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) - study protocol of an open-label trial to investigate the mechanisms underlying the effects of a few-foods diet on ADHD symptoms in children

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029422 ◽  
Author(s):  
Tim Stobernack ◽  
Stefan P W de Vries ◽  
Rob Rodrigues Pereira ◽  
Lidy M Pelsser ◽  
Cajo J F ter Braak ◽  
...  
Keyword(s):  
Well Being ◽  
Adhd Symptoms ◽  
Long Term Effects ◽  
Open Label ◽  
Double Blind ◽  
Adhd Treatment ◽  
Open Label Trial ◽  
Biomarker Research ◽  
The Impact ◽  
Brain Study

IntroductionAttention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child’s development. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Currently, treatment consists of behavioural and pharmacological therapy. However, ADHD medication is associated with several side effects, and concerns about long-term effects and efficacy exist. Therefore, there is considerable interest in the development of alternative treatment options. Double-blind research investigating the effects of a few-foods diet (FFD) has demonstrated a significant decrease in ADHD symptoms following an FFD. However, an FFD requires a considerable effort of both child and parents, limiting its applicability as a general ADHD treatment. To make FFD intervention less challenging or potentially obsolete, we need to understand how, and in which children, an FFD affects ADHD behaviour and, consequently, the child’s well-being. We hypothesise that an FFD affects brain function, and that the nutritional impact on ADHD is effectuated by a complex interplay between the microbiota, gut and brain, that is, the microbiota–gut–brain axis.Methods and analysisThe Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) study is an open-label trial with researchers blinded to changes in ADHD symptoms during sample processing and initial data analyses.Ethics and disseminationThe Medical Research and Ethics Committee of Wageningen University has approved this study (NL63851.081.17, application 17/24). Results will be disseminated through peer-reviewed journal publications, conference presentations, (social) media and the BRAIN study website. A summary of the findings will be provided to the participants.Trial registration numberNCT03440346.Study datesCollection of primary outcome data started in March 2018 and will be ongoing until 100 children have participated in the study. Sample data analysis will start after all samples have been collected.

Symptomatic Treatment With Lanreotide Microparticles in Inoperable Bowel Obstruction Resulting From Peritoneal Carcinomatosis: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

2012 ◽  
Vol 30 (35) ◽  
pp. 4337-4343 ◽  
Author(s):  
Pascale Mariani ◽  
Joëlle Blumberg ◽  
Alain Landau ◽  
Daniela Lebrun-Jezekova ◽  
Estelle Botton ◽  
...  
Keyword(s):  
Peritoneal Carcinomatosis ◽  
Bowel Obstruction ◽  
Well Being ◽  
Symptomatic Treatment ◽  
Phase Iii ◽  
Primary Analysis ◽  
Open Label ◽  
Double Blind ◽  
Parallel Group ◽  
Intent To Treat

Purpose To investigate the somatostatin analog lanreotide as symptomatic treatment for inoperable bowel obstruction due to peritoneal carcinomatosis. Patients and Methods In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase. The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]). Vomiting frequency/NGT secretion volumes, nausea, abdominal pain, well-being, and safety were also assessed. Patients could then enter an open-label lanreotide-only phase. The study was conducted at 22 European hospitals. Results More patients receiving lanreotide than placebo were responders; this difference was not statistically significant for the intent-to-treat (ITT) population on the basis of diary cards (primary analysis; 41.9% [18 of 43] v 29.7% [11 of 37], respectively; odds ratio, 1.75; 95% CI, 0.68 to 4.49; P = .24) but was statistically significant for the corresponding supportive per protocol analysis (57.7% [15 of 26] v 30.4% [seven of 23]; P < .05) and ITT analysis, on the basis of investigators' assessments (50.0% [19 of 38] v 28.6% [10 of 35]; P < .05). Improvements in well-being were significantly greater with lanreotide on days 3, 6, and 7. No significant differences were observed for other secondary end points. Only two (mild/moderate) treatment-emergent adverse events were considered related to lanreotide. Conclusion These results show that lanreotide has some efficacy and is safe in the symptomatic treatment of patients with inoperable bowel obstruction due to peritoneal carcinomatosis.

scholarly journals SAT-044 Treatment of Hypogonadal Men with a New Oral Testosterone Undecanoate (TU) Formulation Improves Psychosexual, Well-Being and Body Composition and Bone Density Parameters

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ronald S Swerdloff ◽  
John K Amory ◽  
Adrian S Dobs ◽  
Christina Wang ◽  
Theodore M Danoff ◽  
...  
Keyword(s):  
Body Composition ◽  
Well Being ◽  
Clinic Visit ◽  
Dose Titration ◽  
Mineral Density ◽  
Open Label ◽  
Testosterone Undecanoate ◽  
Active Comparator ◽  
Sf 36 ◽  
The Impact

Abstract Introduction and Objective: A new, first-in-class oral testosterone (T) replacement therapy product [T-undecanoate (TU) capsules] was recently approved by FDA to treat hypogonadal men. Clinical trials were conducted to evaluate, in part, the impact of oral TU therapy on important secondary efficacy endpoints: Psychosexual and/or general well-being (Trial I and II); and body composition and bone mineral density (BMD) (Trial II). Subject and Methods: Hypogonadal men (AM serum T ≤ 300 ng/dL) age 18 to 65 (Trial I) or 75 years old (Trial II) were randomized into open-label, active-comparator (T-gel/solution) trials. Subjects received: Trial 1: Oral TU (n=166) or a topical T solution (n=55) for 4-6 mos.; or Trial II: Oral TU (n=162) or T-gel (n=163) for 12 mos. The starting oral TU dose (with food) was 237 mg, BID in Trial I and 316 mg, BID in Trial II; up to 2 dose-titration opportunities were available to achieve eugonadal T concentrations (assayed by LC-MS/MS). In Trial I, Psychosexual Daily Questionnaires (PDQ) were completed by study subjects for 7 days at baseline and prior to final clinic visit (Day 105-180). In Trial II, the SF-36 well-being questionnaire was completed on Days 0, 30, 90, 180, 270 and 365 and PDQs were completed for 7 days prior to clinic visits on these same days. In Trial II body composition and BMD was assessed by DEXA scan on Days 0, 180 and 365. Safety was monitored by physical exam and standard clinical lab tests. Results: Mean serum T in response to oral TU was 489 ± 155 ng/dL (mean ± SD) (Trial I) and 628 ± 342 ng/dL (Trial II); 84% of subjects in each trial achieved mean T concentrations in the eugonadal range. Statistically significant mean changes from baseline (p&lt;0.0001) for most SF-36 well-being parameters were observed in both oral TU and T-gel groups. Psychosexual questionnaire results also demonstrated statistically significant improvement over baseline (p&lt;0.0001) in most parameters at Day 30 and all timepoints thereafter in both trials. On Days 180 and 365 (v. baseline) oral TU was associated with a significant reduction in fat mass [-1.92 ± 2.79 (SD) and -2.4 ± 3.6 kg, respectively] (p&lt;0.0001) and an increase in lean body mass [+2.87 ± 2.73 and +3.15 ± 2.69 kg, respectively] (p&lt;0.0001). Oral TU increased mean BMD over baseline on Days 180 and 365 in spine [+0.013 ± 0.035 and +0.018 ± 0.042 g/cm2, respectively (p&lt;0.0001)] and hip [+0.006 ± 0.019 and +0.012 ± 0.023 g/cm2, respectively (p&lt;0.0001)]. Oral TU exhibited a safety profile consistent with commonly prescribed topical T-comparators. Modest increases in cuff sBP of 2.8 ± 11.84 (SD) mm Hg and 1.8 ± 10.76 mm Hg were observed in Trial I for both oral TU and the comparator T-solution. Conclusions: Treatment of hypogonadal men with oral TU yielded circulating mean T concentrations in the mid-eugonadal range and significantly improved psychosexual, general well-being, body composition and BMD parameters comparable to transdermal T administration.

Analysis of the effect of crossover from placebo (PBO) to darolutamide (DARO) on overall survival (OS) benefit in the ARAMIS Trial.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 240-240
Author(s):  
Neal D. Shore ◽  
Karim Fizazi ◽  
Teuvo Tammela ◽  
Murilo Luz ◽  
Manuel Philco Salas ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Safety Profile ◽  
Final Analysis ◽  
Phase Iii ◽  
Sensitivity Analyses ◽  
Primary Analysis ◽  
Open Label ◽  
Double Blind ◽  
Secondary Endpoints ◽  
The Impact

240 Background: DARO is a structurally distinct androgen receptor inhibitor approved for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) based on significantly prolonged metastasis-free survival compared with PBO (median 40.4 vs 18.4 months; hazard ratio [HR] 0.41; 95% confidence interval [CI] 0.34–0.50; P < 0.0001) and a favorable safety profile in the phase III ARAMIS trial. Following unblinding at the primary analysis, crossover from PBO to DARO was permitted for the subsequent open-label treatment phase. Sensitivity analyses were performed to assess the effect of PBO–DARO crossover on OS benefit. Methods: Patients (pts) with nmCRPC receiving androgen deprivation therapy were randomized 2:1 to DARO (n = 955) or PBO (n = 554). In addition to OS, secondary endpoints included times to pain progression, first cytotoxic chemotherapy, first symptomatic skeletal event, and safety. The OS analysis was planned to occur after approximately 240 deaths, and secondary endpoints were evaluated in a hierarchical order. Iterative parameter estimation (IPE) and rank-preserving structural failure time (RPSFT) analyses were performed as pre-planned sensitivity analyses to adjust for the treatment effect of PBO–DARO crossover. The IPE method used a parametric model for the survival times and iteratively determined the model parameter describing the magnitude of the treatment effect, whereas a grid search and non-parametric log-rank test were used for the RPSFT analysis. The IPE and RPSFT analyses both generated a Kaplan–Meier curve for the PBO arm that predicts what would have been observed in the absence of PBO–DARO crossover. Results: After unblinding, 170 pts (30.7% of those randomized to PBO) crossed over from PBO to DARO; median treatment duration from unblinding to the final data cut-off was 11 months. Final analysis of the combined double-blind and open label periods was conducted after 254 deaths (15.5% of DARO and 19.1% of PBO pts) and showed a statistically significant OS benefit for DARO vs PBO (HR 0.69; 95% CI 0.53–0.88; P = 0.003). Results from the IPE (HR 0.66; 95% CI 0.51–0.84; P < 0.001) and RPSFT (HR 0.68; 95% CI 0.51–0.90; P = 0.007) analyses were similar to those from the intention-to-treat population, showing that the impact of PBO–DARO crossover was small. Additional analyses accounting for the effect of PBO–DARO crossover will be presented. The safety profile of DARO continued to be favorable at the final analysis, and discontinuation rates at the end of the double-blind period remained unchanged from the primary analysis (8.9% with DARO and 8.7% with PBO). Conclusions: Early treatment with DARO in men with nmCRPC is associated with significant improvement in OS regardless of pts crossing over from PBO to DARO. The safety profile of DARO remained favorable at the final analysis. Clinical trial information: NCT02200614.

Gamification of nutrition: A preliminary study on the impact of gamification on nutrition knowledge, attitude, and behaviour of adolescents in Nigeria

2018 ◽  
Vol 24 (3) ◽  
pp. 137-144 ◽  
Author(s):  
Obidimma Ezezika ◽  
Jessica Oh ◽  
Ngozi Edeagu ◽  
Warami Boyo
Keyword(s):  
Physical Activity ◽  
Secondary Schools ◽  
Focus Groups ◽  
Eating Behaviour ◽  
Well Being ◽  
Nutrition Knowledge ◽  
Sub Saharan Africa ◽  
Dietary Behaviour ◽  
Long Term Effects ◽  
The Impact

Background: In Nigeria and many parts of sub-Saharan Africa, the availability of foods that are high in salt, sugar, and saturated fat is steadily increasing. This has led to an increase in the consumption of such foods among Nigerians, particularly among adolescents. Aim: This pilot study was undertaken to understand whether, and how, gamification of nutrition can have an impact on addressing the problem of unhealthy eating among Nigerian adolescents. Methods: Gamification of nutrition through board games, clubs and vouchers was introduced in three secondary schools in Abuja, Nigeria over a span of three to four months. Semi-structured focus groups were conducted with grade 11 and 12 students in the three secondary schools. Participants were asked about their perceptions of the intervention and how it influenced their eating behaviour, attitudes and knowledge about nutrition. Results: A total of 31 students participated in four focus groups. Participants reported that the intervention shifted their perceptions and preferences, leading them to alter their behaviour by incorporating more nutritious foods (such as fruits and vegetables) into their diet and engaging in more physical activity. Five themes emerged from the analyses: improved eating behaviour; increased physical activity; improved overall well-being; increased nutrition knowledge; and influencing others. Conclusions: The results from the focus groups suggest that gamification of nutrition can lead to improvements in dietary behaviour among adolescents over the short-term. More studies are needed to evaluate the long-term effects of nutrition interventions that use gamification techniques.

The Impact of ADHD Treatment on Intimate Partner Violence in a Forensic Psychiatry Setting

2019 ◽  
pp. 108705471987950
Author(s):  
Nannet J. L. Buitelaar ◽  
Jocelyne A. Posthumus ◽  
Denise Bijlenga ◽  
Jan K. Buitelaar
Keyword(s):  
Intimate Partner Violence ◽  
Partner Violence ◽  
Forensic Psychiatry ◽  
Adult Adhd ◽  
Combined Treatment ◽  
Intimate Partner ◽  
Longitudinal Impact ◽  
Adhd Symptoms ◽  
Adhd Treatment ◽  
The Impact

Objective: The current longitudinal impact of treatment of ADHD on intimate partner violence (ITAP) study aims to investigate whether decrease of ADHD symptoms is associated with reduction of intimate partner violence (IPV) frequency in IPV offenders with ADHD in a forensic psychiatry setting. Method: Of n = 209 offenders of IPV with ADHD, frequency of IPV and ADHD symptoms were assessed at the 8th, 16th, 24th, and 52nd weeks of their combined treatment for ADHD and IPV. Results: We observed a significant decrease of self-reported ADHD symptoms (large effect size, d ≥ 0.80) and all IPV outcomes (small, d > 0.20, to large, d > 0.80, effect sizes). The decrease in IPV was mainly associated with the decrease in ADHD symptoms. Conclusion: As IPV treatment alone is not effective in the reduction of IPV in forensic psychiatry, we now have strong indications that the combined treatment of adult ADHD and IPV is more effective in offenders with ADHD.

scholarly journals Efficacy and safety of memantine in children with autism spectrum disorder: Results from three phase 2 multicenter studies

Autism ◽  
2019 ◽  
Vol 23 (8) ◽  
pp. 2096-2111 ◽  
Author(s):  
Antonio Y Hardan ◽  
Robert L Hendren ◽  
Michael G Aman ◽  
Adelaide Robb ◽  
Raun D Melmed ◽  
...  
Keyword(s):  
Extended Release ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Social Responsiveness Scale ◽  
Social Responsiveness ◽  
Phase 2 ◽  
Open Label ◽  
Double Blind ◽  
Three Phase ◽  
Open Label Trial

Three phase 2 trials were conducted to assess the efficacy and long-term safety of weight-based memantine extended release (ER) treatment in children with autism spectrum disorder. MEM-MD-91, a 50-week open-label trial, identified memantine extended-release treatment responders for enrollment into MEM-MD-68, a 12-week randomized, double-blind, placebo-controlled withdrawal trial. MEM-MD-69 was an open-label extension trial in which participants from MEM-MD-68, MEM-MD-91, and open-label trial MEM-MD-67 were treated ⩽48 weeks with memantine extended release. In MEM-MD-91, 517 (59.6%) participants were confirmed Social Responsiveness Scale responders at week 12; mean Social Responsiveness Scale total raw scores improved two to three times a minimal clinically important difference of 10 points. In MEM-MD-68, there was no difference between memantine and placebo on the primary efficacy parameter, the proportion of patients with a loss of therapeutic response (defined as ⩾10-point increase from baseline in Social Responsiveness Scale total raw score). MEM-MD-69 exploratory analyses revealed mean standard deviation improvement in Social Responsiveness Scale total raw score of 32.4 (26.4) from baseline of the first lead-in study. No new safety concerns were evident. While the a priori–defined efficacy results of the double-blind trial were not achieved, the considerable improvements in mean Social Responsiveness Scale scores from baseline in the open-label trials were presumed to be clinically important.

scholarly journals Values Narratives for Personal Growth: Formative Evaluation of the Laws of Life Essay Program

2015 ◽  
Vol 59 (2) ◽  
pp. 269-293
Author(s):  
Victoria Banyard ◽  
Sherry Hamby ◽  
Ed de St. Aubin ◽  
John Grych
Keyword(s):  
Character Education ◽  
Process Evaluation ◽  
Personal Growth ◽  
Expressive Writing ◽  
Experimental Studies ◽  
Well Being ◽  
Future Research ◽  
Long Term Effects ◽  
The Impact ◽  
Writing Exercises

Evidence that even very brief writing exercises can change the way people see themselves and promote more positive mental and physical health has led to increased interest in their use in school settings and elsewhere. To date, however, research designs rely heavily on samples of college students and experimental studies of writing tasks carried out in the lab. There has been less investigation of the potential impact of more naturally occurring expressive writing exercises that exist in places like schools and that focus on adolescents. The current study was a process evaluation of the Laws of Life Essay, a values-based narrative program that was part of participants’ secondary school experience. It examined participants’ views of the impact of the program on their personal growth and, given the age range of participants, allowed for process evaluation of its perceived short- and long-term effects. Qualitative, semistructured interviews with 55 adolescent and adult participants were collected. Themes in participants’ responses included the importance of reflection and reappraisal of values, adversity, and relationships. Participants also discussed the importance of an audience for their writing, a novel finding that suggests one possible way to increase the impact of other narrative programs. Participants described variability in their engagement with expressive writing. This is one of the few studies that examined participants’ own views of the value of expressive writing and their responses suggest directions for future research and implications for designing expressive writing tasks to support social emotional learning and character education in schools and promote well-being at key developmental moments.

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