Faculty Bibliography
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205
Post hoc Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder
PMID: 32423239
ISSN: 1557-8992
CID: 4446662
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
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.
PMID: 27521574
ISSN: 1557-1246
CID: 2219202
A Long-Term, Open-Label, Safety Study of Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD
Objective: The aim of this study was to evaluate the long-term safety of triple-bead mixed amphetamine salts (MAS) in adults with ADHD. Method: Adults meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.; DSM-IV-TR) ADHD criteria and satisfying study criteria from one of two antecedent studies were enrolled in this 52-week (dose titration, 4 weeks; dose maintenance, 11 months) open-label extension. The protocol included 12.5- to 75-mg triple-bead MAS but was amended to a maximum of 50-mg triple-bead MAS. Safety evaluations included treatment-emergent adverse events (TEAEs) and vital signs. Clinical outcome measures included ADHD Rating Scale-IV (ADHD-RS-IV) total score changes. Results: Of 505 enrolled participants, 266 completed the study; the M ± SD daily dose during the study was 48.0 ± 15.96 mg. The most frequent TEAEs were insomnia (initial insomnia, insomnia, early morning awakening, middle insomnia; 38.2%), headache (25.7%), and dry mouth (20.2%). Study discontinuations were more frequent with higher doses of triple-bead MAS (37.5-75 mg) than with lower doses (12.5 and 25 mg). Blood pressure and pulse increases were observed at end-of-study. Mean ADHD-RS-IV total score decreases from antecedent study and open-label baselines at end-of-study were -23.3 ± 11.44 and -7.9 ± 13.19, respectively. Conclusion: Triple-bead MAS exhibited a long-term safety profile comparable with previous reports and demonstrated evidence of continued symptom control for up to 12 months.
PMID: 28412886
ISSN: 1557-1246
CID: 4874992
Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD: Results of a Phase 3, Double-Blind, Randomized, Forced-Dose Trial
Objective: Evaluate the efficacy and tolerability of triple-bead mixed amphetamine salts (MAS) in ADHD. Method: Adults with ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥32 were randomized to 6 weeks of triple-bead MAS (25, 50, or 75 mg) or placebo. The primary endpoint was ADHD-RS-IV total score change from baseline at end of study (EOS). Results: Least squares mean (95% confidence interval [CI]) treatment differences for ADHD-RS-IV total score changes from baseline to EOS significantly favored triple-bead MAS (all doses combined: -10.6 [-13.2, -8.0]; p < .0001); there were no significant differences between triple-bead MAS dosages. The most frequently reported TEAEs with triple-bead MAS (all doses combined) included insomnia, decreased appetite, and dry mouth. Mean ± SD pulse and systolic blood pressure increases at EOS were 3.5 ± 10.33 bpm and 0.3 ± 10.48 mmHg with triple-bead MAS (all doses combined). Conclusion: Triple-bead MAS significantly reduced adult ADHD symptoms; the safety profile was consistent with previous triple-bead MAS studies.
PMID: 28413925
ISSN: 1557-1246
CID: 4875002
The Relationship Between Executive Function Deficits and DSM-5-Defined ADHD Symptoms
Objectives: To identify the relationship between the core Diagnostic and Statistical Manual of Mental Disorders (5th ed.) ADHD symptoms and executive function deficits (EFDs), to evaluate ADHD characteristics of those with executive dysfunction (ED), and to examine the predictive utility of the Adult ADHD Investigator Symptom Rating Scale (AISRS) in identifying those with adult ADHD and ED. Method: Two samples (referred and primary care practice) were pooled together for present analysis. Results: Final analysis included 297 respondents, 171 with adult ADHD. Spearman correlation coefficients and binary logistic regressions demonstrated that ADHD inattentive (IA) and hyperactive-impulsive (H-I) symptoms were moderately to strongly correlated with and highly predictive of EFDs. Receiver operating characteristic curve analysis showed that an AISRS DSM 18-item score of ⩾ 28 was most predictive of clinical ED. Conclusion: ADHD symptoms were strongly correlated with and predictive of EFDs, clinicians should screen adults with ADHD for EFDs and ADHD treatment providers should track EFD improvement in addition to DSM-5 ADHD symptoms.
PMID: 30296883
ISSN: 1557-1246
CID: 4261832
"The World Health Organization Adult Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5": Correction
Reports an error in "The World Health Organization Adult Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5" by Berk Ustun et al. (JAMA Psychiatry, 2017[May], Vol 74[5], 520-526). In the original article, there were errors in the footnote to Table 1 and in a corresponding section of Results. In Table 1 footnote a, the phrase "the highest scores are 5 for questions 1 and 2" should have read "the highest scores are 6 for question 3, 5 for questions 1 and 2," and the range given as "the range 0 of 24" should have been "in the range of 0 to 25." The corresponding 2 mentions in the Results of "0to 24" should have been "0to 25." This article was also corrected on October 25, 2017, to fix an error in Results. This article was corrected online. (The abstract of the original article appeared in record 2017-32659-009). Importance: Recognition that adult attention-deficit/hyperactivity disorder (ADHD) is common, seriously impairing, and usually undiagnosed has led to the development of adult ADHD screening scales for use in community, workplace, and primary care settings. However, these scales are all calibrated to DSM-IV criteria, which are narrower than the recently developed DSM-5 criteria. Objectives: To update for DSM-5 criteria and improve the operating characteristics of the widely used World Health Organization Adult ADHD Self-Report Scale (ASRS) for screening. Design, setting, and participants: Probability subsamples of participants in 2 general population surveys (2001-2003 household survey [n = 119] and 2004-2005 managed care subscriber survey [n = 218]) who completed the full 29-question self-report ASRS, with both subsamples over-sampling ASRS-screened positives, were blindly administered a semistructured research diagnostic interview for DSM-5 adult ADHD. In 2016, the Risk-Calibrated Supersparse Linear Integer Model, a novel machine-learning algorithm designed to create screening scales with optimal integer weights and limited numbers of screening questions, was applied to the pooled data to create a DSM-5 version of the ASRS screening scale. The accuracy of the new scale was then confirmed in an independent 2011-2012 clinical sample of patients seeking evaluation at the New York University Langone Medical Center Adult ADHD Program (NYU Langone) and 2015-2016 primary care controls (n = 300). Data analysis was conducted from April 4, 2016, to September 22, 2016. Main outcomes and measures: The sensitivity, specificity, area under the curve (AUC), and positive predictive value (PPV) of the revised ASRS. Results: Of the total 637 participants, 44 (37.0%) household survey respondents, 51 (23.4%) managed care respondents, and 173 (57.7%) NYU Langone respondents met DSM-5 criteria for adult ADHD in the semistructured diagnostic interview. Of the respondents who met DSM-5 criteria for adult ADHD, 123 were male (45.9%); mean (SD) age was 33.1 (11.4) years. A 6-question screening scale was found to be optimal in distinguishing cases from noncases in the first 2 samples. Operating characteristics were excellent at the diagnostic threshold in the weighted (to the 8.2% DSM-5/Adult ADHD Clinical Diagnostic Scale population prevalence) data (sensitivity, 91.4%; specificity, 96.0%; AUC, 0.94; PPV, 67.3%). Operating characteristics were similar despite a much higher prevalence (57.7%) when the scale was applied to the NYU Langone clinical sample (sensitivity, 91.9%; specificity, 74.0%; AUC, 0.83; PPV, 82.8%). Conclusions and relevance: The new ADHD screening scale is short, easily scored, detects the vast majority of general population cases at a threshold that also has high specificity and PPV, and could be used as a screening tool in specialty treatment settings.
PSYCH:2019-76060-017
ISSN: 2168-6238
CID: 4381412
Healthcare provider perspectives on diagnosing and treating adults with attention-deficit/hyperactivity disorder
Objective: This study examined adult attention-deficit/hyperactivity disorder (ADHD) screening and management patterns among healthcare provider (HCP) subgroups. Methods: An online survey of US-based HCPs (neurologists, n=200; nurse practitioners [NPs], n=100; psychiatrists, n=201; primary care physicians [PCPs], n=201) was conducted from May to June 2017. The survey assessed issues relating to adult ADHD screening and management and HCP perceptions of factors influencing patient choice of pharmacotherapy. Participants were required to be experienced in diagnosing and/or treating ADHD in adults (≥5 patients/month for neurologists and NPs; ≥10 patients/month for psychiatrists and PCPs). Results: Significantly greater percentages of psychiatrists than non-psychiatrists were confident in diagnosing ADHD (P<0.001) and screened/evaluated for ADHD in patients with depression/anxiety disorders (P<0.001). Significantly greater percentages of psychiatrists versus non-psychiatrists prescribed once-daily long-acting (LA) stimulants (71.6% vs 62.2%; P=0.023) or short-acting (SA) stimulants more than once daily (40.3% vs 29.7%; P=0.009) as first-line therapy. In contrast, a significantly greater percentage of non-psychiatrists than psychiatrists prescribed once-daily SA stimulants (32.9% vs 17.4%; P<0.001). Psychiatrist and non-psychiatrist HCPs viewed insurance coverage/treatment costs (79.9%), perceived duration of effect (72.2%), and side effects (66.5%) as important factors to patients when choosing treatment. HCPs reported that the greatest mean ± SD percentages of patients changed their treatment regimen in the past 6 months because of perceptions of insufficient duration of effect (35.4%±22.1%) and lack of efficacy (30.3%±21.0%). Conclusion: Compared with psychiatrists, non-psychiatrists exhibited less confidence in diagnosing adult ADHD and experienced greater difficulty determining optimal treatment regimens.
PMID: 31340712
ISSN: 1941-9260
CID: 3988112
The Adult ADHD Quality Measures Initiative
Objective: Quality measures (QMs; also known as Quality Indicators) quantify health care processes, outcomes, patient perceptions, and organizational structure and/or systems that are relevant to the provision of high-quality health care. We describe the first phase of a project that has as its ultimate goal the creation and validation of QMs for tracking the screening, diagnosis, treatment, and clinical follow-up of adults with ADHD. This will fill an important gap in the field of Adult ADHD because QMs for adult ADHD do not exist. Method: We followed the guidelines of the U.S. Agency for Healthcare Research and Quality (AHRQ) for the development of QMs. These guidelines call for two phases: (1) Identify Candidate QMs and (2) Assess Candidate QMs. This article describes the results of our Phase 1 activities. To generate QMs for adult ADHD, we took the following steps: (a) searched the clinical/research literature for adult ADHD QMs; (b) convened a multidisciplinary panel comprising clinical and research experts and had them brainstorm potential QMs in the areas of screening, diagnosis, treatment, follow-up, care coordination, and patient experience; (c) compared these QMs with existing guidelines for adult ADHD to see if any potential QMs had been missed, this led to a draft list of 46 QMs; (d) had 28 ADHD experts rate the importance, reliability, validity, feasibility, and usability of the QMs. Results: The literature review found several QMs for ADHD in youth but none for ADHD in adults. The brainstorming session generated 52 QMs. The survey showed that all of these QMs were highly rated but that there was sufficient variability in ratings to prioritize some QMs over others. Conclusion: Based on these results, we prioritized QMs to carry forward into the next phase of the project. This work fills an important gap for the clinical care of adult patients with ADHD and helps to set a precedent for mental health, which has lagged behind other areas of medicine in developing QMs.
PMID: 30511593
ISSN: 1557-1246
CID: 3990562
Validation of the Expanded Versions of the Adult ADHD Self-Report Scale v1.1 Symptom Checklist and the Adult ADHD Investigator Symptom Rating Scale
Objective: The aim of this study is to validate the Adult ADHD Self-Report Scale (ASRS) and Adult ADHD Investigator Symptom Rating Scale (AISRS) expanded versions, including executive function deficits (EFDs) and emotional dyscontrol (EC) items, and to present ASRS and AISRS pilot normative data. Method: Two patient samples (referred and primary care physician [PCP] controls) were pooled together for these analyses. Results: Final analysis included 297 respondents, 171 with adult ADHD. Cronbach's alphas were high for all sections of the scales. Examining histograms of ASRS 31-item and AISRS 18-item total scores for ADHD controls, 95% cutoff scores were 70 and 23, respectively; histograms for pilot normative sample suggest cutoffs of 82 and 26, respectively. Conclusion: (a) ASRS- and AISRS-expanded versions have high validity in assessment of core 18 adult ADHD Diagnostic and Statistical Manual of Mental Disorders (DSM) symptoms and EFD and EC symptoms. (b) ASRS (31-item) scores 70 to 82 and AISRS (18-item) scores from 23 to 26 suggest a high likelihood of adult ADHD.
PMID: 29419345
ISSN: 1557-1246
CID: 3990542
Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial
OBJECTIVE:Dasotraline is a potent inhibitor of presynaptic dopamine and norepinephrine reuptake with a pharmacokinetic profile characterized by slow absorption and a long elimination half-life. The aim of this study was to evaluate the efficacy and safety of dasotraline in children with attention-deficit/hyperactivity disorder (ADHD). METHODS:Children aged 6-12 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ADHD were randomized to 6 weeks of double-blind once-daily treatment with dasotraline (2 or 4 mg) or placebo. The primary efficacy endpoint was change from baseline in the ADHD Rating Scale Version IV-Home Version (ADHD RS-IV HV) total score at week 6. RESULTS:A total of 342 patients were randomized to dasotraline or placebo (mean age 9.1 years, 66.7% male). Treatment with dasotraline was associated with significant improvement at study endpoint in the ADHD RS-IV HV total score for the 4 mg/day dose versus placebo (-17.5 vs. -11.4; p < 0.001; effect size [ES], 0.48), but not for the 2 mg/day dose (-11.8 vs. -11.4; ns; ES, 0.03). A regression analysis confirmed a significant linear dose-response relationship for dasotraline. Significant improvement for dasotraline 4 mg/day dose versus placebo was also observed across the majority of secondary efficacy endpoints, including the Clinical Global Impression (CGI)-Severity score, the Conners Parent Rating Scale-Revised scale (CPRS-R) ADHD index score, and subscale measures of hyperactivity and inattentiveness. Discontinuation rates due to adverse events (AEs) were higher in the dasotraline 4 mg/day group (12.2%) compared with the 2 mg/day group (6.3%) and placebo (1.7%). The most frequent AEs associated with dasotraline were insomnia, decreased appetite, decreased weight, and irritability. Psychosis-related symptoms were reported as AEs by 7/219 patients treated with dasotraline in this study. There were no serious AEs or clinically meaningful changes in blood pressure or heart rate on dasotraline. CONCLUSION/CONCLUSIONS:In this placebo-controlled study, treatment with dasotraline 4 mg/day significantly improved ADHD symptoms and behaviors, including attention and hyperactivity, in children aged 6-12 years. The most frequently reported AEs observed on dasotraline included insomnia, decreased appetite, decreased weight, and irritability.
PMID: 30694697
ISSN: 1557-8992
CID: 3626562
