Executive Functioning Outcomes Over 6 Months of Atomoxetine for Adults With ADHD: Relationship to Maintenance of Response and Relapse Over the Subsequent 6 Months After Treatment

2016 ◽  
Vol 24 (3) ◽  
pp. 363-372 ◽  
Author(s):  
Lenard A. Adler ◽  
Mary Solanto ◽  
Rodrigo Escobar ◽  
Sarah Lipsius ◽  
Himanshu Upadhyaya

Objective: This study examines the relationship between maintenance of improved executive functioning (EF) in adults with ADHD with long-term symptom improvement with atomoxetine. Method: Data were collected from a yearlong, double-blind, placebo-controlled clinical study on adult patients with ADHD receiving atomoxetine (80-100 mg/day) for 24 weeks. Patients were then randomized to continue atomoxetine or placebo for 6 months. Executive functioning was rated with Behavior Rating Inventory of Executive Function–Adult Version: Self-Report™ (BRIEF-A: Self-Report™), and the T-scores were determined. Results: Postrandomization T-scores for atomoxetine patients were significantly better than those of placebo patients (3 and 6 months postrandomization). Patients with greater improvements in EF were more likely to show worsening of EF and to relapse after atomoxetine discontinuation. The maintenance of improved EF was significantly associated with improved ADHD symptoms (Conners’ Adult ADHD Rating Scale–Investigator Rated: Screening Version [CAARS-Inv:SV] with adult prompts). Conclusion: Treatment with atomoxetine improved EF during the treatment phases. Improved EF was maintained up to 6 months after discontinuation of atomoxetine.

2018 ◽  
Vol 24 (3) ◽  
pp. 425-433 ◽  
Author(s):  
Joseph Ben-Sheetrit ◽  
Miriam Peskin ◽  
Jeffrey H. Newcorn ◽  
Yaron Daniely ◽  
Liat Shbiro ◽  
...  

Objective: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. Method: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners’ Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. Results: Pre–post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p < .00001, F(2.8, 383.0) = 43.1, p < .00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. Conclusion: In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator–rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.


2020 ◽  
pp. 108705471990025
Author(s):  
Saleh M. H. Mohamed ◽  
Norbert A. Börger ◽  
Jaap J. van der Meere

Objectives: Many studies have indicated a close relationship between ADHD and mood symptoms in university students. In the present study, we explore the role of daily functional impairments and executive functioning in the ADHD–mood relationship. Method: A total of 343 adults (126 males) filled out (a) the Conners’ Adult ADHD Rating Scale, (b) the Depression Anxiety and Stress Scale, (c) the Weiss Functional Impairment Rating Scale, and (d) the Executive Function Index Scale. Results: The correlation between mood symptoms and ADHD was .48 (moderate correlation) and dropped to .15 (weak correlation) when controlling for functional problems and executive functioning. Hierarchical regression analyses showed that both functional impairments and executive functioning significantly explained 42% to 53% of the variance of mood symptoms. The addition of ADHD symptoms to the model slightly increased the explained mood variance by only 1%. Conclusion: These findings underline the role of experienced difficulties in triggering mood symptoms in ADHD symptomatology.


CNS Spectrums ◽  
2005 ◽  
Vol 10 (S20) ◽  
pp. 16-25 ◽  
Author(s):  
Joseph Biederman ◽  
Thomas J. Spencer ◽  
Timothy E. Wilens ◽  
Richard H. Weisler ◽  
Stephanie C. Read ◽  
...  

AbstractObjective: Assess the long-term safety and effectiveness of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype.Methods: A 24-month, open-label extension of a 4-week, multicenter, double-blind, placebo-controlled, parallel-group, forced–dose-escalation study of MAS XR in adults (≥ 18 years of age) with ADHD. The 223 enrolled subjects started treatment at 20 mgl day for 1 week, with subsequent titration up to 60 mgl day for optimal therapeutic effects. At monthly visits, efficacy was assessed based on the ADHD Rating Scale IV (ADHD-RS-N). Safety assessments included spontaneously reported adverse events, laboratory assessments, and monitoring of vital signs.Findings: ADHD symptoms significantly improved for all subjects as measured by change from baseline in mean ADHD-RS-IV total scores (-7.2±13.04 unit points; P<.001); this was sustained for up to 24 months. The most common treatment-related adverse events were dry mouth (43% of subjects reporting at least one occurrence), infection (33%), insomnia (32%), anorexia/decreased appetite (32%), headache (30%), and nervousness (26%). Most adverse events were mild to moderate in intensity.Conclusion: Treatment with MAS XR 20–60 mgl day for adult ADHD was generally well tolerated and was associated with sustained symptomatic improvement for up to 24 months.


2016 ◽  
Vol 23 (13) ◽  
pp. 1557-1566 ◽  
Author(s):  
Joseph Ben-Sheetrit ◽  
Mika Zurawel ◽  
Abraham Weizman ◽  
Iris Manor

Objective: The aim of this study is to explore the connections within and between three measures of adult ADHD: the Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A)–Self-Report, Conners’ Adult ADHD Rating Scale–Investigator-Rated (CAARS-Inv), and Test of Variables of Attention (TOVA). Method: Data of 89 adults with ADHD (ages = 18-54, 46% females) who were assessed using these measures during pretreatment visits of a randomized study of metadoxine XR were analyzed. Results: The CAARS-Inv and TOVA did not correlate. The BRIEF-A correlated extensively with both the CAARS-Inv and TOVA, primarily via its Behavioral Regulation Index (BRI). The BRIEF-A Metacognition Index correlated with the CAARS-Inv inattentive score, while the BRI correlated with the CAARS-Inv hyperactive-impulsive score. Within the CAARS and TOVA, inattention and hyperactivity-impulsivity correlated weakly. Conclusion: The measures seem to capture different aspects of adult ADHD. While the CAARS-Inv addresses mainly the domain of symptoms, and the TOVA that of impairment, the BRIEF-A captures aspects of both.


2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Kathryn Peterson ◽  
Mirna Chehade ◽  
Joseph Murray ◽  
Gary Falk ◽  
Nirmala Gonsalves ◽  
...  

Abstract   Eosinophilic esophagitis (EoE), gastritis (EG), and/or duodenitis (EoD) are associated with accumulation and activation of eosinophils and mast cells in the esophagus, stomach, and/or duodenum, respectively. Lirentelimab (AK002), an antibody against siglec-8, depletes eosinophils and inhibits mast cells. We performed an open-label extension (OLE) study of subjects who completed ENIGMA (a randomized, double-blind, placebo-controlled phase 2 study of lirentelimab in adults with symptomatic, biopsy-confirmed EG and/or EoD, with or without EoE) to evaluate long-term responses. Methods Subjects who received 4 monthly infusions of lirentelimab or placebo during ENIGMA (n = 59) were eligible for the OLE; they received monthly, escalating doses of lirentelimab (0.3 or 1 mg/kg escalating to 3 mg/kg). Symptoms were assessed weekly using an electronic daily patient-reported outcome questionnaire and total symptom scores (TSS) were calculated. Patients underwent upper endoscopy with biopsy at screening and at the end of ENIGMA (day 99, week 16, blinded); in the OLE, endoscopies were performed on day 323 (30 weeks after the first dose in the OLE). Histopathology was assessed by a single pathologist. Results Fifty-eight subjects entered the OLE; 45 completed ≥52 weeks lirentelimab (including exposure during ENIGMA) and 29 completed 70 weeks. Mean TSS improved through week 70 (Figure 1). Subjects receiving 70 weeks lirentelimab (ENIGMA+OLE) had further improvements in TSS from baseline (mean reductions: 68% at weeks 29–30, 70% at weeks 51–52, 75% at weeks 69–70). Symptom scores (abdominal pain, nausea, vomiting, early satiety, appetite loss, abdominal cramping, bloating, diarrhea) decreased significantly from baseline. Treatment response was not associated with concomitant EoE. The most common adverse event was mild to moderate infusion-related reactions, usually with the first infusion. Conclusion In the OLE of the ENIGMA study, patients with EG and or EoD (with or without concomitant EoE) who received lirentelimab had sustained tissue eosinophil depletion and significant long-term symptom improvement. Symptoms continued to improve with duration of treatment. Lirentelimab appears to be a promising targeted treatment for EG and/or EoD.


2017 ◽  
Vol 24 (6) ◽  
pp. 928-942 ◽  
Author(s):  
Lotte Janssen ◽  
Alicia M. de Vries ◽  
Sevket Hepark ◽  
Anne E. M. Speckens

Objective: Mindfulness-Based Cognitive Therapy (MBCT) is a promising psychosocial intervention for adult ADHD. The feasibility and effectiveness of an adapted MBCT program is explored, together with the possible process of change. Method: Mixed-method study with 31 ADHD patients participating in an adapted MBCT program. Self-report questionnaires on ADHD symptoms, executive functioning, mindfulness skills, self-compassion, patient functioning, and health status were administered before and after MBCT. Semi-structured interviews were conducted with 24 patients. Results: A modest drop-out of n = 5 (16%) was found. MBCT resulted in a significant reduction of ADHD symptoms and improvements of executive functioning, self-compassion, and mental health. Qualitative analysis provided insight in facilitators and barriers participants experienced, and their process of change. Conclusion: The adapted MBCT program seemed to be feasible for adults with ADHD and preliminary evidence for the effectiveness is shown. An adequately powered Randomized Controlled Trial (RCT) is needed to further examine the effectiveness of MBCT for ADHD.


Assessment ◽  
2021 ◽  
pp. 107319112110556
Author(s):  
Stephen L. Aita ◽  
Grant G. Moncrief ◽  
Jennifer Greene ◽  
Sue Trujillo ◽  
Alicia Carrillo ◽  
...  

The Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A) is a standardized rating scale of subjective executive functioning. We provide univariate and multivariate base rates (BRs) for scale/index scores in the clinical range ( T scores ≥65), reliable change, and inter-rater information not included in the Professional Manual. Participants were adults (ages = 18–90 years) from the BRIEF-A self-report ( N = 1,050) and informant report ( N = 1,200) standardization samples, as well as test–retest ( n = 50 for self, n = 44 for informant) and inter-rater ( n = 180) samples. Univariate BRs of elevated T scores were low (self-report = 3.3%–15.4%, informant report = 4.5%–16.3%). Multivariate BRs revealed the common occurrence of obtaining at least one elevated T-score across scales (self-report = 26.5%–37.3%, informant report = 22.7%–30.3%), whereas virtually none had elevated scores on all scales. Test–retest scores were highly correlated (self = .82–.94; informant = .91–.96). Inter-rater correlations ranged from .44 to .68. Significant ( p < .05) test–retest T-score differences ranged from 7 to 12 for self-report, from 6 to 8 for informant report, and from 16 to 21 points for inter-rater T-score differences. Applications of these findings are discussed.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Weidong Pan ◽  
Qiudong Wang ◽  
Shin Kwak ◽  
Yu Song ◽  
Baofeng Qin ◽  
...  

We evaluated the effects of the traditional Chinese medicine (TCM) Shen-Zhi-Ling oral liquid (SZL) on the behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer’s disease (AD). Among 98 patients with AD and BPSD enrolled (mean age, 57.2 ± 8.9 years old), 91 (M = 55,F = 36; mean age, 57.2 ± 9.7 years old) completed the study. Patients took either SZL (n=45) or placebo granules (n=46) in a double-blind manner for 20 weeks while maintaining other anticognitive medications unchanged. Changes in BPSD between week 0, week 10, week 20, and week 25 were assessed using the behavioral pathology in Alzheimer’s disease (BEHAVE-AD) rating scale and the neuropsychiatric inventory (NPI), detrended fluctuation analysis (DFA) represented by diurnal activity (DA), evening activity (EA), and nocturnal activity (NA) according to actigraphic recordings. SZL but not placebo oral liquid delayed the development of BPSD significantly according to the changes in some of the clinical scores and the EA and NA parameters of DFA at week 20 compared with week 0. No side effects were observed in laboratory tests. The results indicate that SZL might delay the development of BPSD in AD patients and thus is a potentially suitable drug for long-term use.


2020 ◽  
Vol 35 (6) ◽  
pp. 940-940
Author(s):  
Coddaire K ◽  
Peyton L ◽  
Powell J ◽  
Virden T

Abstract Objective This study aimed to determine the relationship between symptom self-report accuracy and objective cognitive functioning in multiple cognitive domains for varying neurocognitive impairment (NCI) subsequent to Traumatic Brain Injury (TBI). Specifically, the discrepancy between self-report and objective findings among participants with mild, moderate, and severe NCI was examined within the cognitive domains of Attention, Executive Functioning, Learning/Memory, and Speech/Language. Method The sample included archival data consisting of neuropsychological scores and self-reported Ruff Neurobehavioral Inventory (RNBI) results of 135 adult TBI patients with mild, moderate, or severe NCI who received neuropsychological assessment at a private practice. Patients were grouped based on level of impairment using Halstead Impairment Index criteria. Results No main effect was found for Attention. Patients with severe NCI had greater discrepancies in Executive Functioning (p = 0.015), Learning/Memory (p = 0.015), and Speech/Language (p &lt; 0.001) function, when compared to those with mild NCI. Additionally, patients with severe NCI demonstrated greater discrepancies in Speech/Language (p &lt; 0.001) function when compared to those with moderate NCI. Conclusion These findings indicate as severity of neurocognitive impairment increases for TBI patients, self-reported cognitive symptomatology—specifically executive functioning, learning/memory, and speech/language—will become less accurate. Clinically, these findings suggest that when working with patients who have severe neurocognitive deficits subsequent to TBI, it is important to consider objective testing as self-reporting may not be accurate. Understanding patient’s genuine deficits will foster patient awareness and acceptance of TBI-related cognitive deficits with increased investment in treatment and improved neurorehabilitation outcomes.


2019 ◽  
Vol 33 (4) ◽  
pp. 511-521 ◽  
Author(s):  
Joseph Biederman ◽  
Annika Lindsten ◽  
Lasse B Sluth ◽  
Maria Louise Petersen ◽  
Anders Ettrup ◽  
...  

Background: Stimulants remain the mainstay of treatment for attention-deficit hyperactivity disorder (ADHD) but are often associated with insufficient response or poor tolerability, leading to many patients not wishing to be treated with controlled substances. Aims: This randomized, placebo-controlled, proof-of-concept study (NCT02327013) evaluated the efficacy of a multimodal antidepressant, vortioxetine, in the treatment of ADHD, using a two-stage sequential parallel comparison design. Methods: Patients aged 18–55 years with a diagnosis of ADHD (DSM-5) and a total score ⩾24 on the Adult ADHD Investigator Symptom Rating Scale (AISRS) were randomized in study stage I with a 1:1:3 ratio to six weeks of treatment with vortioxetine 10 or 20 mg/day, or placebo ( n = 227). In study stage II, placebo non-responders (AISRS total score reduction <30% from stage I baseline) were re-randomized with a 1:1:1 ratio to six weeks of vortioxetine 10 or 20 mg/day, or placebo ( n = 59). Results: Across the two study stages combined, ADHD symptoms improved by approximately eight AISRS points in all treatment groups, showing no difference from placebo for either dose of vortioxetine, the study thus failing to meet its primary endpoint. However, both doses of vortioxetine separated from placebo in improving overall patient functioning, as measured by the Sheehan Disability Scale. Conclusion: Studies are warranted to further investigate this suggested benefit of a multimodal antidepressant for patient functioning in ADHD while addressing issues of non-adherence and placebo response. The study confirmed vortioxetine 10 mg and 20 mg as generally well-tolerated.


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