scholarly journals Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Scott H. Kollins ◽  
Ann Childress ◽  
Andrew C. Heusser ◽  
Jacqueline Lutz
Keyword(s):  
Video Game ◽  
Primary Outcome ◽  
Rating Scale ◽  
Stimulant Medication ◽  
Additional Treatment ◽  
Adhd Medication ◽  
Open Label ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Hyperactivity Disorder

AbstractSTARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

scholarly journals StopWatch: Pilot study for an Apple Watch application for youth with ADHD

2021 ◽  
Vol 7 ◽  
pp. 205520762110012
Author(s):  
John E Leikauf ◽  
Carlos Correa ◽  
Andrew N Bueno ◽  
Vicente Peris Sempere ◽  
Leanne M Williams
Keyword(s):  
Pilot Study ◽  
Mixed Models ◽  
Rating Scales ◽  
Haptic Feedback ◽  
Rating Scale ◽  
Open Label ◽  
Software Application ◽  
Hyperactivity Disorder ◽  
Further Development ◽  
Youth With Adhd

Introduction To address the need for non-pharmacologic, scalable approaches for managing attention-deficit and hyperactivity disorder (ADHD) in young people, we report the results of a study of an application developed for a wearable device (Apple Watch) that was designed to track movement and provide visual and haptic feedback for ADHD. Methods Six-week, open label pilot study with structured rating scales ADHD and semi-structured qualitative interview. Apple Watch software application given to users that uses actigraphy and graphic interface as well as haptic feedback to provide feedback to users about level of movement during periods of intentional focus. Linear mixed models to estimate trajectories. Results Thirty-two participants entered the study. This application was associated with improvement in ADHD symptoms over the 6 weeks of the study. We observed an ADHD-Rating Scale change of β = −1.2 units/week (95% CI = −0.56 to −1.88, F = 13.4, P = .0004). Conclusions These positive clinical outcomes highlight the promise of such wearable applications for ADHD and the need to pursue their further development.

scholarly journals Effects and feasibility of hyperthermic baths in comparison to exercise as add-on treatment to usual care in depression: a randomised, controlled pilot study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Johannes Naumann ◽  
Iris Kruza ◽  
Luisa Denkel ◽  
Gunver Kienle ◽  
Roman Huber
Keyword(s):  
Pilot Study ◽  
Usual Care ◽  
Rating Scale ◽  
Water Immersion ◽  
Exercise Program ◽  
Moderate Intensity ◽  
Current Therapy ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomised Controlled

Abstract Background Limitations of current therapy of depression highlight the need for an immediately available, easily implementable add-on treatment option with high acceptance from patients. Hyperthermic baths (HTB) are a form of balneotherapy with head-out-of-water-immersion in a hot pool or tub at 40 °C for 15–20 min. A prior study suggests that HTB added to usual depression care can have antidepressant effects. Method Single-site, open-label randomised controlled 8-week parallel-group pilot study at a university outpatient clinic. 45 medically stable outpatients with moderate depression as determined by the 17-item Hamilton Depression Rating Scale (HAM-D) score ≥ 18 and a score ≥ 2 on item 1 (Depressed Mood) were recruited. They were randomised to twice weekly HTB (n = 22) or a physical exercise program (PEP) of moderate intensity (n = 23). Primary outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). Linear regression analyses, adjusted for baseline values, were performed to estimate intervention effects on an intention-to-treat (ITT) and per-protocol (PP) principle. Results Forty-five patients (HTB n = 22; PEP n = 23) were analyzed according to ITT (mean age = 48.4 years, SD = 11.3, mean HAM-D score = 21.7, SD = 3.2). Baseline-adjusted mean difference after 2 weeks was 4.3 points in the HAM-D score in favor of HTB (p < 0.001). Compliance with the intervention and follow-up was far better in the HTB group (2 vs 13 dropouts). Per protocol analysis only showed superiority of HTB as a trend (p = 0.068). There were no treatment-related serious adverse events. Main limitation: the number of dropouts in the PEP group (13 of 23) was higher than in other trials investigating exercise in depression. Due to the high number of dropouts the effect in the ITT-analysis may be overestimated. Conclusions HTB added to usual care may be a fast-acting, safe and easy accessible method leading to clinically relevant improvement in depression severity after 2 weeks; it is also suitable for persons who have problems performing exercise training. Trial registration German Clinical Trials Register (DRKS) with the registration number DRKS00011013 (registration date 2016-09-19) before onset of the study.

scholarly journals Objective Evaluation of Therapeutic Effects of ADHD Medication Using a Smart Watch: A Pilot Study

2020 ◽  
Vol 10 (17) ◽  
pp. 5946
Author(s):  
Chen-Sen Ouyang ◽  
Rei-Cheng Yang ◽  
Ching-Tai Chiang ◽  
Rong-Ching Wu ◽  
Lung-Chang Lin
Keyword(s):  
Rating Scale ◽  
Objective Evaluation ◽  
Therapeutic Effects ◽  
Adhd Medication ◽  
Objective Method ◽  
Analog Scale ◽  
Hyperactivity Disorder ◽  
Smart Watch ◽  
Before And After ◽  
Adhd Medications

Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder in schoolchildren. Several methods are used to evaluate ADHD therapeutic effects, including the Swanson, Nolan, and Pelham (SNAP) questionnaire, the Vanderbilt ADHD Diagnostic Rating Scale, and the visual analog scale. However, these scales are subjective. In this study, we employed an objective method to evaluate the aforementioned therapeutic effects. Ten patients (nine boys and one girl) with ADHD were enrolled. An accelerometer was embedded in a smart watch to record the movements of patients with ADHD. The variance values of the accelerometer before and after one month of medication (methylphenidate) use were compared. The results demonstrated that the variance values along the y- and z-axes of the accelerometers significantly decreased after one month of methylphenidate use. Before and after one month of methylphenidate use, the variance values were 4.4227 ± 2.1723 and 2.3214 ± 0.6475 (p = 0.0119) on the y-axis, and 4.0933 ± 1.5720 and 2.4091 ± 0.8141 (p = 0.0140) on the z-axis, respectively. In addition, the correlation was moderate-to-strong between the SNAP hyperactivity subscale and variance along the y-axis. Thus, a smart watch with an accelerometer inside is potentially an objective and useful method for evaluating the therapeutic effects of ADHD medications.

scholarly journals Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

2019 ◽  
Vol 79 (2) ◽  
pp. 276-284 ◽  
Author(s):  
Edward Roddy ◽  
Kris Clarkson ◽  
Milica Blagojevic-Bucknall ◽  
Rajnikant Mehta ◽  
Raymond Oppong ◽  
...  
Keyword(s):  
Primary Care ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Low Dose ◽  
Rating Scale ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Open Label ◽  
Gout Flare ◽  
Gout Flares

ObjectivesTo compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.MethodsThis was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0–10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1–7 by intention to treat.ResultsBetween 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1–7 (colchicine vs naproxen: mean difference −0.18; 95% CI −0.53 to 0.17; p=0.32). During days 1–7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).ConclusionWe found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.Trial registration numberISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine: a two-phase, multicentre, randomized, double-blind clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Le Xiao ◽  
Xuequan Zhu ◽  
Amy Gillespie ◽  
Yuan Feng ◽  
Jingjing Zhou ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Additional Treatment ◽  
Combination Group ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement

Abstract Background This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment. Methods This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization. Results A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects. Conclusions After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.

scholarly journals Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study

2015 ◽  
Vol 42 (5) ◽  
pp. 799-809 ◽  
Author(s):  
Atsushi Ogata ◽  
Koichi Amano ◽  
Hiroaki Dobashi ◽  
Masayuki Inoo ◽  
Tomonori Ishii ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Additional Treatment ◽  
Joint Disease ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
American College Of Rheumatology ◽  
Open Label Extension

Objective.To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA).Methods.Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks.Results.The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy.Conclusion.TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

Combined treatment with reboxetine in depressed patients with no response to venlafaxine: a 6-week follow-up study

2007 ◽  
Vol 19 (5) ◽  
pp. 291-296 ◽  
Author(s):  
Cecilio Álamo ◽  
Francisco López-Muñoz ◽  
Gabriel Rubio ◽  
Pilar García-García ◽  
Antonio Pardo
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Combined Treatment ◽  
Open Label ◽  
Serious Adverse Events ◽  
Multicentric Study ◽  
Intent To Treat ◽  
Events Data ◽  
Clinical Global Impression Improvement

Objective:The purpose of present study was to evaluate the efficacy of the addition of reboxetine in patients that had not previously responded, or had done so only partially, over 6 weeks of conventional pharmacological treatment with venlafaxine.Methods:This open-label, prospective and multicentric study included 40 outpatients diagnosed with major depressive disorder according to the DSM-IV criteria. Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HAMD) and the Clinical Global Impression-Improvement (CGI-I). Safety was evaluated by recording spontaneously reported adverse events. Data were analysed on an intent-to-treat basis, using the last-observation-carried-forward method.Results:Mean HAMD reduction was 34.9% (P < 0.0001). The percentages of responders (≥50% reduction in HAMD) and patients considered as benefiting from complete remission (HAMD ≤ 10 points) at week 6 were 27.5 and 12.5%, respectively. By the end of the treatment, the score of CGI-I decreased 24.8% (P < 0.0001). Percentage of patient improving (CGI < 4 points) was 47.5%. The most common non-serious adverse events were constipation, nervousness, anxiety and insomnia.Conclusion:These findings suggest that the combined treatment of reboxetine and venlafaxine, in venlafaxine-resistant patients, may be an effective and well-tolerated strategy.

scholarly journals Convalescent plasma for hospitalized patients with COVID-19 and the effect of plasma antibodies: a randomized controlled, open-label trial

2021 ◽  
Author(s):  
Philippe Bégin ◽  
Jeannie Callum ◽  
Erin Jamulae Jamula ◽  
Richard Cook ◽  
Nancy M Heddle ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Harmful Effect ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Open Label ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Negative Results ◽  
Intent To Treat

The efficacy of convalescent plasma for COVID-19 is unclear. While most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content may influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients were allocated 2:1 to 500 mL of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 days. The effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. 940 patients were randomized and 921 patients were included in the intent-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) in the convalescent plasma arm and 86/307 (28.0%) in the standard of care arm; relative risk (RR) 1.16 (95% confidence interval (CI) 0.94-1.43; p=0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% vs. 26.4%; RR=1.27, 95% CI 1.02-1.57, p=0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standard log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (OR=0.74; 0.57-0.95 and OR=0.66; 0.50-0.87, respectively), while IgG against the full transmembrane Spike protein increased it (OR=1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 days among hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavourable antibody profiles may be associated with worse clinical outcomes compared to standard care.

scholarly journals Evaluation of a novel 5 day accelerated 1 Hz repetitive transcranial magnetic stimulation protocol in major depression

2020 ◽  
Author(s):  
Jean-Philippe Miron ◽  
Molly Hyde ◽  
Linsay Fox ◽  
Jack Sheen ◽  
Helena Voetterl ◽  
...  
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Delayed Effect ◽  
Open Label ◽  
Serious Adverse Events ◽  
Resting Motor Threshold ◽  
Dorsolateral Prefrontal ◽  
The Right

BACKGROUND Repetitive transcranial magnetic stimulation (rTMS) is an effective intervention in major depressive disorder (MDD) but requires daily travel to a treatment clinic over several weeks. Shorter rTMS courses retaining similar effectiveness would thus increase the practicality and scalability of the technique, and therefore its accessibility. OBJECTIVE We assessed the feasibility of a novel 5 day accelerated 1 Hz rTMS protocol. We hypothesized that this novel rTMS protocol would be safe and well-tolerated while shortening the overall treatment course. METHODS We conducted a prospective, single-arm, open-label feasibility study. Thirty (30) participants received a one-week (5 days) accelerated (8 sessions per day, 40 sessions total) course of 1 Hz rTMS (600 pulses per session, 50-minute intersession interval) over the right dorsolateral prefrontal cortex (R-DLPFC) using a figure-of-eight coil at 120% of the resting motor threshold (rMT). Depression severity was assessed on the Beck Depression Inventory-II (BDI-II) and 17-item Hamilton Rating Scale for Depression (HRSD-17). RESULTS Response and remission rates 1 week after treatment were 33.3% and 13.3% respectively and increased to 43.3% and 30.0% at 4 weeks after treatment. No serious adverse events occurred. All participants reported manageable pain levels. CONCLUSION 1 Hz rTMS administered 8 times daily for 5 days is safe and well-tolerated. Efficacy at the end of the course was similar to a standard daily course of 1 Hz rTMS, and there appears to be an additional delayed effect. Further validation in a randomized trial is required.

scholarly journals Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e056091
Author(s):  
James Rucker ◽  
Hassan Jafari ◽  
Tim Mantingh ◽  
Catherine Bird ◽  
Nadav Liam Modlin ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Informed Consent ◽  
Depressive Disorder ◽  
Primary Outcome ◽  
Rating Scale ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Feasibility Trial ◽  
Open Label ◽  
Major Depressive

IntroductionPsilocybin-assisted therapy may be a new treatment for major depressive disorder (MDD), with encouraging data from pilot trials. In this trial (short name: PsiDeR) we aimed to test the feasibility of a parallel-group, randomised, placebo-controlled design. The primary outcomes in this trial are measures of feasibility: recruitment rates, dropout rates and the variance of the primary outcome measure of depression.Methods and analysisWe are recruiting up to 60 participants at a single centre in London, UK who are unresponsive to, or intolerant of, at least two evidence-based treatments for MDD. Participants are randomised to receive a single dosing session of 25 mg psilocybin or a placebo. All participants receive a package of psychological therapy. The primary outcome measure for depression is the Montgomery Asberg Depression Rating Scale collected by blinded, independent raters. The primary endpoint is at 3 weeks, and the total follow-up is 6 weeks. With further informed consent, this study collects neuroimaging and omics data for mechanism and biomarker analyses and offers participants an open label extension consisting of a further, open label dose of 25 mg of psilocybin.Ethics and disseminationAll participants will be required to provide written informed consent. The trial has been authorised by the National Research Ethics Committee (20-LO/0206), Health Research Authority (252750) and Medicine’s and Healthcare Products Regulatory Agency (CTA 14523/0284/001-0001) in the UK. Dissemination of results will occur via a peer-reviewed publication and other relevant media.Trial registration numbersEUDRACT2018-003573-97; NCT04959253.

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