Memantine in the Treatment of Executive Function Deficits in Adults With ADHD

2016 ◽  
Vol 21 (4) ◽  
pp. 343-352 ◽  
Author(s):  
Joseph Biederman ◽  
Ronna Fried ◽  
Laura Tarko ◽  
Craig Surman ◽  
Thomas Spencer ◽  
...  
Keyword(s):  
Executive Function ◽  
Stimulant Medication ◽  
Small Sample Size ◽  
Neuropsychological Test ◽  
Small Sample ◽  
Open Label ◽  
Double Blind ◽  
Adjunct Treatment ◽  
Behavior Rating Inventory ◽  
Executive Function Deficits

Objective: To evaluate the efficacy and safety of memantine hydrochloride as an adjunct to stimulant pharmacotherapy for treating executive function deficits (EFDs) in adults with ADHD. Method: This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. Because of the small sample size, we considered a standardized mean difference (equivalent to effect size) of ≥0.5 and odds ratios ≥2 as indicators of trend improvements. Results: Twelve participants received memantine and 14 received a placebo. Trend improvements favoring memantine were observed on Behavior Rating Inventory of Executive Functions–Adult Inhibition and Self-Monitor subscales when compared with Placebo. No significant changes were noted on the Cambridge Neuropsychological Test Automated Battery. Conclusion: Among adults with ADHD and EFDs, adjunct treatment with memantine to osmotic release oral system-methylphenidate (OROS-MPH) was associated with improvements in selective areas of executive functioning, supporting the need for further research.

scholarly journals P336 Association between the prior duration of remission and efficacy outcomes in patients with Ulcerative Colitis treated with tofacitinib 10 mg twice daily who were in stable remission and either dose-reduced to tofacitinib 5 mg twice daily or remained on 10 mg twice daily: 6-month data from the double-blind, randomised RIVETING study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S361-S362
Author(s):  
M C Dubinsky ◽  
G R D’Haens ◽  
W J Sandborn ◽  
S C Ng ◽  
J Panés ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Dose Reduction ◽  
Small Sample Size ◽  
Small Sample ◽  
Open Label ◽  
Double Blind ◽  
Treatment Groups ◽  
Mayo Score ◽  
Remission Duration ◽  
To Receive

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). RIVETING (NCT03281304) is an ongoing, double-blind, randomised, parallel-group study designed to evaluate the efficacy and safety of dose reduction to tofacitinib 5 mg twice daily (BID) vs remaining on 10 mg BID in patients (pts) with UC in stable remission on tofacitinib 10 mg BID maintenance therapy. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension study (NCT01470612), and had been in stable remission for ≥6 months (M) and corticosteroid-free for ≥4 weeks prior to enrolment.1 We aimed to evaluate the association between the duration of remission prior to enrolment into RIVETING and the efficacy of tofacitinib 5 and 10 mg BID. Methods Pts who were in partial Mayo score (PMS) remission (a PMS of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0) at RIVETING baseline were included in this analysis. Pts were randomised to dose-reduce to tofacitinib 5 mg BID or remain on 10 mg BID. We evaluated efficacy endpoints at Month 6 in RIVETING, stratified by duration of PMS remission (0–12, 12–24, 24–36, 36–48, >48 M) at RIVETING baseline. Results At RIVETING baseline, 139 of 140 pts were in PMS remission: 69 pts dose-reduced to tofacitinib 5 mg BID and 70 pts remained on tofacitinib 10 mg BID. In both treatment groups, compared with pts with <24M of PMS remission, baseline modified Mayo and total Mayo scores were numerically lower in pts with a PMS remission duration of >24M; these pts also generally had a numerically lower change from baseline modified Mayo and total Mayo scores at Month 6 (Table). At Month 6, following dose reduction to tofacitinib 5 mg BID, PMS remission was maintained in 66.7%, 60.0%, 82.4%, 75.0% and 90.0% of pts with baseline PMS remission durations of 0–12M, 12–24M, 24–36M, 36–48M and >48M, respectively. Corresponding values for pts who continued to receive tofacitinib 10 mg BID were 80.0%, 88.9%, 91.7%, 100.0% and 100.0%. At Month 6, the proportion of pts achieving modified Mayo remission, remission and modified PMS remission was generally higher in pts with baseline PMS remission of >24M vs pts with PMS remission of <24M across treatment groups (Table). Conclusion Following dose reduction from tofacitinib 10 to 5 mg BID, rates of modified Mayo remission, remission and PMS remission were numerically higher in pts with a PMS remission duration of >24M vs pts with <24M of PMS remission duration. The same trend was observed in pts who continued to receive tofacitinib 10 mg BID. These analyses are post hoc and limited by the small sample size. Reference

A-146 Parent Responses on the Behavior Rating Inventory of Executive Function-2 Are more Reflective of Child Cognitive Functioning than Teacher Responses

2021 ◽  
Vol 36 (6) ◽  
pp. 1200-1200
Author(s):  
Kera Larson ◽  
Jessica Wilbur ◽  
Elizabeth Hamilton
Keyword(s):  
Executive Function ◽  
Auditory Processing ◽  
Small Sample Size ◽  
Rural School ◽  
Small Sample ◽  
Behavior Rating ◽  
Fourth Edition ◽  
Intellectual Performance ◽  
Behavior Rating Inventory ◽  
Moderate Relationship

Abstract Objective The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is widely used to assess executive processes in children and adolescents. The BRIEF-2 manual (2015) indicates small correlations between executive functioning and intellectual performance on the Wechsler Intelligence Scales for Children, Fourth Edition, but no studies have evaluated the BRIEF-2 and the Woodcock Johnson Tests of Cognitive Abilities, Fourth Edition (WJ-IV-Cog). The current study examined whether parent and teacher BRIEF-2 responses were linked to WJ-IV-Cog indices in a rural school-based sample. Method A sample of (n = 18) students attending rural school districts was extracted from an archival dataset. Participants (age range 7–17, M = 12.9, SD = 2.5) included 15 males and 3 females, who were referred for psychoeducational assessment. Results Correlational analyses indicated a moderate relationship between the BRIEF-2 parent Global Executive Composite (GEC) and the WJ-IV-Cog domains of comprehension-knowledge (Gc), fluid reasoning (Gf), and auditory processing (Ga) (p < 0.05). Subsequent analyses of the three BRIEF-2 indices showed that the Parent Behavioral Regulation Index (BRI) was related to both Gc and Gf (p < 0.05), while the Parent Cognitive Regulation Index (CRI) was significantly associated with Gc, Gf, and Ga (p < 0.05). Teacher ratings of GEC, BRI, and CRI were independent from child intellectual performance. However, Teacher Emotion Regulation Index (ERI) was moderately related with GIA (p < 0.05). Conclusion Current findings support a moderate relationship between parent ratings on the BRIEF-2 and specific cognitive domains on the WJ-IV-Cog. Results should be interpreted within the context of both a small sample size and the designation of subjects for psycho-educational assessment evaluations.

scholarly journals P409 Non-invasive predictors of maintaining remission in patients with moderately to severely active Ulcerative Colitis treated with tofacitinib who dose-reduced from tofacitinib 10 mg twice daily to 5 mg twice daily: 6-month data from the double-blind, randomised RIVETING study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S416-S417
Author(s):  
G R D’Haens ◽  
M C Dubinsky ◽  
M Regueiro ◽  
G O Santana ◽  
J Torres ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Dose Reduction ◽  
Small Sample Size ◽  
Small Sample ◽  
Open Label ◽  
Double Blind ◽  
Faecal Calprotectin ◽  
Reactive Protein ◽  
Mayo Score ◽  
Over Time

Abstract Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). RIVETING (NCT03281304) is an ongoing, double-blind, randomised, parallel-group study designed to evaluate the efficacy and safety of dose reduction to tofacitinib 5 mg twice daily (BID) vs remaining on 10 mg BID in patients (pts) with UC in stable remission on tofacitinib 10 mg BID maintenance therapy. Eligible pts had received tofacitinib 10 mg BID for ≥2 consecutive years in an open-label, long-term extension study (NCT01470612), and had been in stable remission for ≥6 months and corticosteroid-free for ≥4 weeks prior to enrolment.1 We aimed to determine if faecal calprotectin (FCP), C-reactive protein (CRP) or partial Mayo score (PMS) can be used as predictors of maintaining remission after dose reduction. Methods Median FCP levels, median CRP levels and mean PMS at baseline (BL), Month 1 and Month 3 were analysed by efficacy endpoint status at Month 6 in pts who dose-reduced to tofacitinib 5 mg BID. The proportions of pts who achieved efficacy endpoints at Month 6 were analysed by stool frequency (SF) subscore, rectal bleeding (RB) subscore and modified PMS. Results Seventy pts were randomised to receive tofacitinib 5 mg BID in RIVETING. For pts in modified Mayo score remission at Month 6, PMS was relatively stable over time, whereas PMS increased from BL to Month 1 and Month 3 in pts not in modified Mayo score remission at Month 6; mean change from BL at Month 3 was 0.1 vs 0.7, respectively (Table 1). This trend was also observed for other efficacy endpoints (Table 1). Median FCP levels did not change from BL to Month 3 in pts who achieved Month 6 efficacy endpoints, whereas median FCP levels increased from BL to Month 3 in pts who did not achieve Month 6 efficacy endpoints (except remission) (Table 1). For all efficacy endpoints, no trend was observed in median CRP levels over time in pts who did and did not achieve Month 6 efficacy endpoints (Table 1). A numerically higher proportion of pts with a SF subscore, RB subscore or modified PMS of 0 at Month 1 or Month 3 achieved efficacy endpoints at Month 6 compared with pts with respective subscores >0 (Table 2). Conclusion These analyses suggest that in pts previously in stable remission, an increase in FCP levels at Month 3, or PMS as early as Month 1, may help predict loss of efficacy after dose-reduction from tofacitinib 10 mg BID to 5 mg BID. A SF subscore, RB subscore or modified PMS of 0 at either Month 1 or Month 3 could indicate the likelihood of maintaining efficacy with tofacitinib 5 mg BID at Month 6. These analyses are post hoc, exploratory and limited by the small sample size. Reference

Adjunctive memantine in clozapine-treated refractory schizophrenia: an open-label 1-year extension study

2016 ◽  
Vol 47 (2) ◽  
pp. 363-375 ◽  
Author(s):  
S. R. T. Veerman ◽  
P. F. J. Schulte ◽  
J. B. Deijen ◽  
L. de Haan
Keyword(s):  
Executive Function ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Neuropsychological Test ◽  
Extension Study ◽  
Favourable Effect ◽  
Long Term Effects ◽  
Open Label ◽  
Double Blind ◽  
Beneficial Effects

BackgroundIn a recent placebo-controlled, double-blind crossover trial (n = 52), significant beneficial effects on memory (d = 0.30) and negative symptoms (d = 0.29) were found after 12 weeks of memantine augmentation in patients with clozapine-refractory schizophrenia. In this open-label 1-year extension study we report the long-term effects and tolerability of memantine add-on therapy to clozapine.MethodCompleters of the first trial who experienced beneficial effects during 12 weeks of memantine treatment received memantine for 1 year. Primary endpoints were memory and executive function using the Cambridge Neuropsychological Test Automated Battery, the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression Severity Scale (CGI-S).ResultsOf 31 randomized controlled trial completers who experienced beneficial effects from memantine, 24 received memantine for 1 year. The small improvement in memory found in the memantine condition in the placebo-controlled trial remained stable in the extension study. Executive function did not improve. After 26 weeks of memantine add-on therapy to clozapine, PANSS negative symptoms (r = 0.53), PANSS positive symptoms (r = 0.50) and PANSS total symptoms (r = 0.54) significantly improved. Even further significant improvement in all these measures was observed between 26 weeks and 52 weeks of memantine, with effect sizes varying from 0.39 to 0.51. CGI-S showed a non-significant moderate improvement at 26 weeks (r = 0.36) and 52 weeks (r = 0.34). Memantine was well tolerated without serious adverse effects.ConclusionsIn the 1-year extension phase the favourable effect of adjunctive memantine on memory was sustained and we observed further improvement of negative, positive and overall symptoms in patients with clozapine-treated refractory schizophrenia.

Comparative Efficacy of Once Daily Loratadine versus Terfenadine in the Treatment of Allergic Rhinitis

1989 ◽  
Vol 17 (2) ◽  
pp. 150-156 ◽  
Author(s):  
C. H. Banov
Keyword(s):  
Allergic Rhinitis ◽  
Initial Dose ◽  
Small Sample Size ◽  
Small Sample ◽  
Double Blind ◽  
Once Daily ◽  
Excellent Response ◽  
Parallel Group ◽  
Parallel Group Trial ◽  
Group Trial

This 1 week study compared the efficacy of once daily administration of 10 mg loratadine with 120 mg terfenadine in out-patients with seasonal allergic rhinitis. It focussed on the efficacy of treatment at the end of the 24 h period following a daily dose. The study was designed as a double-blind, randomized, parallel-group trial, and 41 patients were enrolled and evaluated for efficacy. Patients took an initial dose at the study site and returned on days 2 and 8. At day 2 (24 h after the initial dose), according to the physician's evaluation 57% of loratadine-treated patients had a good or excellent response, compared to 50% of those given terfenadine. At day 8, 24 h after the final dose, 71% of the loratadine-treated patients and 35% of the terfenadine-treated patients had a good or excellent response ( P = 0.03). At days 2 and 8, reductions in mean symptom scores measured 22, 23 and 24 h after the initial and final doses showed an indication of being greater with loratadine than with terfenadine (non-significant due to small sample size). The incidence of sedation was similar in both groups. It is concluded that 10 mg loratadine, administered once daily, controls the symptoms of rhinitis more effectively than 120 mg terfenadine given once daily in the last few hours of the 24 h dosing period.

scholarly journals Review of the Studies in the Use of Biofeedback Therapy in Rehabilitation and Physiatrics of Neurological Patients

Doctor Ru ◽  
2021 ◽  
Vol 20 (9) ◽  
pp. 43-47
Author(s):  
E.Yu. Mozheyko ◽  
◽  
O.V. Petryaeva ◽  
◽  
◽  
...  
Keyword(s):  
Large Scale ◽  
Small Sample Size ◽  
Small Sample ◽  
Healthy Population ◽  
Biofeedback Therapy ◽  
Level Of Evidence ◽  
Double Blind ◽  
Key Points ◽  
Neurological Patients ◽  
Drug Free

Objective of the Review: To collect information, analyse and evaluate previous studies in the use of biofeedback in neurological patients. Key Points. Despite the wide practical application and a lot of available publications, the level of evidence of this method is low because of a small sample size and the challenges with biofeedback mechanism description. A review of various types of biocontrol, its mechanisms and developments shows that drug-free therapy using only patient’s resources (organic, psychological, emotional and volitional) can activate the mechanisms of neuroplasticity, which are poorly studied. Still, it does not prevent from using biocontrol for the therapy of patients and/or prevention of various diseases in healthy population. Conclusion. Biofeedback therapy has proven to be a safe, relatively efficient and easy-to-use method. However, organisation of a large-scale double blind randomized trial is one of the predominant directions in the future. Keywords: biofeedback, biocontrol, neurofeedback, biofeedback therapy.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

Effect of coadministration of propranolol and etodolac (VT-122) plus sorafenib for patients with advanced hepatocellular carcinoma (HCC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 390-390 ◽  
Author(s):  
Andrew N de la Torre ◽  
Ismael Castaneda ◽  
Aram F. Hezel ◽  
Newell F. Bascomb ◽  
Gouri Shankar Bhattacharyya ◽  
...  
Keyword(s):  
Hepatitis Virus ◽  
Small Sample Size ◽  
Small Sample ◽  
Controlled Study ◽  
Advanced Hepatocellular Carcinoma ◽  
Separate Study ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Duration Of Therapy ◽  
Significant Efficacy

390 Background: Propranolol and etodolac (designated VT-122) target the adrenergic and prostaglandin stress systems activated in HCC. These stress-induced systems are proposed to induce changes in the tumor microenvironment and immune system leading to tumor promotion and immune tolerance. In a separate study, administration of VT-122 prior to sorafenib showed an increase in median overall survival (OS) of 21 months when VT-122 is administered before sorafenib compared to 10 months OS for sorafenib alone. The aim of the current study was to evaluate the effect of administering VT-122 at least 30 days after starting sorafenib. Methods: Patients with HCC receiving sorafenib for at least 30 days were eligible for this double-blind, placebo-controlled study. Patients were randomized to receive sorafenib with either VT-122 or placebo. Patients received therapy for up to 12 months or until treatment failure. VT-122 was administered twice daily. The primary endpoint was duration of therapy (DoT) and the secondary endpoint was OS. Results: Twenty patients were randomized, 11 and 9 patients to the VT122 and placebo arm, respectively. Each arm was balanced with regards to age (mean of 60.4 years), Child Pugh status (9 Child Pugh A, 11 Child Pugh B7), hepatitis virus status (6 HBV and 1 HCV positive) and C-reactive protein (CRP) (20.4 mg/L). VT122 with sorafenib was well tolerated with no unexpected serious adverse events reported. Mean OS was 13.9 months and 9.6 months in the VT-122 and placebo arms, respectively. Mean DoT (unvalidated) was 10.1 months and 7.5 months in the VT-122 and placebo arms, respectively. Conclusions: Co-administration of VT-122 with sorafenib was well tolerated and showed an increase in duration of therapy and OS versus sorafenib alone. The small sample size and number of events precludes the ability to make any significant efficacy conclusions. The increase in survival was not as great as that seen in a separate study in which VT122 was started prior to sorafenib. A further Phase 3 study of VT122 administered prior to sorafenib in patients with HCC is warranted. Clinical trial information: NCT01265576.

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