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A Single-Blind, Placebo Controlled Trial of Triple Beaded Mixed Amphetamine Salts in DSM-5 Adults With ADHD Assessing Effects Throughout the Day
Adler, Lenard A; Anbarasan, Deepti; Sardoff, Taylor; Leon, Terry; Gallagher, Richard; Massimi, Caleb A; Faraone, Stephen V
OBJECTIVE/UNASSIGNED:To examine the effects of triple beaded mixed amphetamine salts (TB MAS) on ADHD and executive dysfunction symptoms throughout the day in adults with DSM-5 ADHD. METHOD/UNASSIGNED:This was a 6 week, single-blind, placebo-lead in trial of TB MAS (12.5-37.5 mg/day); all participants received 2 weeks of single-blind placebo); one individual was a placebo responder and was discontinued. One of these 18 dropped after 1 week on 12.5 mg/day, while all others completed the trial and received 37.5 mg/day TB MAS. RESULTS/UNASSIGNED:There were significant effects of TB MAS on all clinical measures, including investigator overall symptoms (AISRS); self-report overall (ASRS), time-sensitive ADHD (TASS) scores throughout the day, impairment (CGI) and executive function scores (BRIEF-A). TB MAS was generally well tolerated. CONCLUSIONS/UNASSIGNED:This study extends prior findings of TB MAS to adults with DSM-5 ADHD; it further re-validates findings of efficacy of TB MAS throughout the day.
PMID: 38214178
ISSN: 1557-1246
CID: 5645572
Measuring Quality Care for Adult ADHD Patients: How Much Does Gender and Gender Identity Matter?
Clay, Tarin; Callen, Elisabeth F; Alai, Jill; Goodman, David W; Adler, Lenard A; Faraone, Stephen V
OBJECTIVE/UNASSIGNED:Studies show adult ADHD presents differently in men and women, however few studies contrast ADHD in cisgender and gender diverse adults. We assessed care differences between these groups using previously identified quality measures (QMs). METHODS/UNASSIGNED:Using EHR data, we matched a group of male ADHD patients to a female group. We followed the same procedure with a cisgender group and one identified as gender diverse through a gender dysphoria diagnosis. QM achievement was measured using logistic regression models. RESULTS/UNASSIGNED:Most QMs exhibited increasing achievement over time for all groups. Variations in care quality between males and females persisted, with female patients achieving QMs more often. There were no appreciable differences between the cisgender and gender diverse groups. CONCLUSION/UNASSIGNED:Though quality care for adult ADHD improved from 2010 to 2020, differences between male and female patients lingered. This effect was not observed in cisgender and gender diverse patients.
PMID: 38156652
ISSN: 1557-1246
CID: 5633092
Amygdala-derived-EEG-fMRI-pattern neurofeedback for the treatment of chronic post-traumatic stress disorder. A prospective, multicenter, multinational study evaluating clinical efficacy
Fruchter, Eyal; Goldenthal, Nadav; Adler, Lenard A; Gross, Raz; Harel, Eiran V; Deutsch, Lisa; Nacasch, Nitsa; Grinapol, Shulamit; Amital, Daniela; Voigt, Jeffrey D; Marmar, Charles R
We conducted a prospective, single arm, multisite, multinational, open label trial assessing the safety and efficacy of a novel amygdala derived neurofeedback treatment, designated Amygdala-Derived-EFP, for chronic PTSD. Participants, including veterans and civilians, underwent screening, training, 15 neurofeedback sessions over 8 weeks and; baseline, termination (8 weeks) and 3 month post treatment assessments with validated measures. The primary endpoint was more than 50 % of the participants demonstrating a Minimally Clinically Important Difference (MCID) defined as a 6-point reduction, on the Clinician Administered PTSD Scale (CAPS-5) total score at 3 months. Secondary measures included the PCL-5, ERQ, PHQ-9, and CGI. Statistical analyses were performed using SAS®V9.4. The primary endpoint was met, with a CAPS-5 MCID response rate of 66.7 %. The average reduction in CAPS-5 total scores at 3 month follow up was 13.5 points, more than twice the MCID. Changes from baseline in CAPS-5, PCL-5, PHQ-9 scores at 8 weeks and the 3 month follow-up demonstrated statistically significant improvements in response and; demonstrated effect sizes ranging from 0.46 to 1.07. Adverse events were mild and resolved after treatment. This study builds on prior research demonstrating similar outcomes using amygdala-derived neurofeedback. Positive attributes of this therapy include monitoring by non-physician personnel, affordability, accessibility, and tolerability.
PMID: 38325159
ISSN: 1872-7123
CID: 5632712
The Times, They Are a-Changing at Psychiatric Annals
Nierenberg, Andrew A.; Adler, Lenard
SCOPUS:85183054285
ISSN: 0048-5713
CID: 5629262
A Single-Blind, Placebo Controlled Trial of Triple Beaded Mixed Amphetamine Salts in DSM-5 Adults With ADHD Assessing Effects Throughout the Day
Adler, Lenard A.; Anbarasan, Deepti; Sardoff, Taylor; Leon, Terry; Gallagher, Richard; Massimi, Caleb A.; Faraone, Stephen V.
Objective: To examine the effects of triple beaded mixed amphetamine salts (TB MAS) on ADHD and executive dysfunction symptoms throughout the day in adults with DSM-5 ADHD. Method: This was a 6 week, single-blind, placebo-lead in trial of TB MAS (12.5"“37.5 mg/day); all participants received 2 weeks of single-blind placebo); one individual was a placebo responder and was discontinued. One of these 18 dropped after 1 week on 12.5 mg/day, while all others completed the trial and received 37.5 mg/day TB MAS. Results: There were significant effects of TB MAS on all clinical measures, including investigator overall symptoms (AISRS); self-report overall (ASRS), time-sensitive ADHD (TASS) scores throughout the day, impairment (CGI) and executive function scores (BRIEF-A). TB MAS was generally well tolerated. Conclusions: This study extends prior findings of TB MAS to adults with DSM-5 ADHD; it further re-validates findings of efficacy of TB MAS throughout the day.
SCOPUS:85182249728
ISSN: 1087-0547
CID: 5629842
Differences in Primary Care Management of Patients With Adult Attention Deficit Hyperactivity Disorder (ADHD) Based on Race and Ethnicity
Alai, Jillian; Callen, Elisabeth F.; Clay, Tarin; Goodman, David W.; Adler, Lenard A.; Faraone, Stephen V.
Objective: Examine differences in care patterns around adult ADHD between race (White/Non-White) and ethnic (Hispanic/Non-Hispanic) groups utilizing existing quality measures (QMs), concerning diagnosis, treatment, and medication prescribing. Methods: The AAFP National Research Network in partnership with SUNY Upstate Medical used an EHR dataset to evaluate achievement of 10 ADHD QMs. The dataset was obtained from DARTNet Institute and includes 4 million patients of 873 behavioral and primary care practices with at least 100 patients from 2010 to 2020. Patients 18-years or older with adult ADHD were included in this analysis. Results: White patients and Non-Hispanic/Latinx patients were more likely to achieve these QMs than White patients and Hispanic/Latinx patients, respectively. Differences between groups concerning medication and monitoring demonstrate a disparity for Non-White and Hispanic/Latinx populations. Conclusions: Using QMs in EHR data can help identify gaps in ADHD research. There is a need to continue investigating disparities of quality adult ADHD care.
SCOPUS:85182214377
ISSN: 1087-0547
CID: 5629862
Pilot Study of Prism EFP NeuroFeedback in Adult ADHD
Adler, Lenard A; Anbarasan, Deepti; Leon, Terry; Sardoff, Taylor; Descorbeth, Olivia; Cho, Dayeon; Stern, Yaki; Kraft, Oded; Hendler, Talma; Marmar, Charles R
OBJECTIVE/UNASSIGNED:A pilot study to preliminarily examine the effects of Prism EFP NeuroFeedback (NF) in adult ADHD. METHOD/UNASSIGNED:Prism EFP NF is a form of NF specifically designed to target emotional dysregulation (ED) through down regulation of amygdala activity. Prism EFP NF has been shown to improve other disorders with significant ED. Nine participants with adult ADHD received an open trial of Prism EFP NF consisting of fifteen sessions over 8 weeks; all completed at least 5 weeks of treatment with seven completing all 8 weeks. Outcomes were assessed by change in ADHD symptoms from baseline to End of Treatment. RESULTS/UNASSIGNED:About two-third reduction was seen in total DSM ADHD symptom scores (primary outcome measure) with improvement observed in all other clinical measures. No significant adverse events were seen. CONCLUSION/UNASSIGNED:This preliminary trial found substantial effects of Prism EFP NF on ADHD/ED symptoms and global impairment.
PMID: 38152997
ISSN: 1557-1246
CID: 5623272
Progress and Pitfalls in the Provision of Quality Care for Adults With Attention Deficit Hyperactivity Disorder in Primary Care
Callen, Elisabeth F; Clay, Tarin L; Alai, Jillian; Goodman, David W; Adler, Lenard A; Shields, Joel; Faraone, Stephen V
OBJECTIVE/UNASSIGNED:Quality care for attention deficit hyperactivity disorder (ADHD) in adults has lagged behind other psychiatric disorders. We sought to assess how the achievement of quality measures (QMs) for diagnosing and treating ADHD in adults has changed over time. METHOD/UNASSIGNED:We assessed 10 QMs in electronic health records (EHRs) from primary care and behavioral health clinics from 2010 to 2020 for 71,310 patients diagnosed with ADHD. RESULTS/UNASSIGNED:< .001). Some showed increases to high levels; others remained low throughout the observation period. No patients achieved more than six of 10 QMs in any year. Small but significant effects for sex, race, ethnicity, practice ownership, practice type, and age. CONCLUSION/UNASSIGNED:Increase in quality care from 2010 to 2020 along with clear evidence that more efforts are needed to improve quality of care for adults with ADHD seen in primary care.
PMID: 36803110
ISSN: 1557-1246
CID: 5466952
Measuring Quality Care for Adult ADHD Patients: How Much Does Gender and Gender Identity Matter?
Clay, Tarin; Callen, Elisabeth F.; Alai, Jill; Goodman, David W.; Adler, Lenard A.; Faraone, Stephen V.
Objective: Studies show adult ADHD presents differently in men and women, however few studies contrast ADHD in cisgender and gender diverse adults. We assessed care differences between these groups using previously identified quality measures (QMs). Methods: Using EHR data, we matched a group of male ADHD patients to a female group. We followed the same procedure with a cisgender group and one identified as gender diverse through a gender dysphoria diagnosis. QM achievement was measured using logistic regression models. Results: Most QMs exhibited increasing achievement over time for all groups. Variations in care quality between males and females persisted, with female patients achieving QMs more often. There were no appreciable differences between the cisgender and gender diverse groups. Conclusion: Though quality care for adult ADHD improved from 2010 to 2020, differences between male and female patients lingered. This effect was not observed in cisgender and gender diverse patients.
SCOPUS:85181203058
ISSN: 1087-0547
CID: 5631012
The Role of Age in Adult ADHD Quality Care: A Longitudinal Analysis of Electronic Health Record Data
Callen, Elisabeth F.; Clay, Tarin; Alai, Jillian; Goodman, David W.; Adler, Lenard A.; Faraone, Stephen V.
Objective: Several studies have shown that Adult ADHD presents differently in younger and older adults. We sought to assess the difference in care between these two groups using previously identified quality measures (QMs). Methods: Using electronic health record data, we matched a younger group of ADHD patients to an older group. We then assessed the achievement of the QMs using probit models with and without interaction terms. Results: The majority of QMs shown an increase in achievement for both groups over time. However, significant differences in quality of care between younger and older adult ADHD patients persisted. By the end of the study period, with the exception of three QMs, younger patients achieved the QMs more. Conclusion: While, in general, the quality of care for adult ADHD increased from 2010 to 2020, there were still differences in care between younger and older adult ADHD patients.
SCOPUS:85181226614
ISSN: 1087-0547
CID: 5630982