The investigators are conducting a 10-week brain imaging and medication study. They are doing the research to study the response of Attention-Deficit/ Hyperactivity Disorder (ADHD) in youth with Autism Spectrum Disorder (ASD) on extended-release formulation of mixed amphetamine salts (MAS) (also know as Adderall XR). The investigators also want to find out if taking MAS has any effect on the brains of children and adolescents with ADHD and ASD. This study will help researchers better understand how the use of MAS to treat ADHD effects children and adolescents with ASD. The investigators will compare MAS to a placebo. The placebo will look exactly like the MAS capsules but will contain no MAS. During this study, participants may get a placebo instead of MAS. Placebos are used in research studies to see if the study results are due to the study drug or due to other reasons.
Participants with ASD and ADHD will complete 4-weeks of treatment with the study medication or placebo. They will complete bi-weekly study visits virtually via a telemedicine platform with the study doctor and complete questionnaires. On alternating weeks, they will meet with a Massachusetts General Hospital (MGH) study team member to discuss medication adherence and potential side effects. Participants will have the option to attend all study visits in-person if participants prefer. They will also complete baseline and endpoint Magnetic Resonance (MR) scan visits at Massachusetts Institute of Technology (MIT). During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.
Participants without ADHD or ASD will complete eligibility screening with MGH. If eligible, they will be invited to baseline and endpoint MR scan visits at MIT. During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.

Start Date01 Aug 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT04635826

/ WithdrawnPhase 4IIT

The Role of Expectancy for Cognitive Enhancement in College Students Using Prescription Stimulants Nonmedically

We propose to evaluate the interaction between expectations of receiving stimulants, neurophysiological activity and enhancement of cognitive performance using fMRI.

Start Date01 Jul 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05650775

/ CompletedPhase 1IIT

Biomarkers of ADHD Treatment Response

The goal of this translational biomarker study is to use electroencephalography (EEG) to identify brain signatures that will predict a child's response to two of the most commonly prescribed ADHD medications, methylphenidate and mixed amphetamine salts. The main questions the investigators aim to answer are:
1. Do children with ADHD who show symptom reduction with methylphenidate have different EEG profiles than children who do not respond well to methylphenidate?
2. Do children who respond better to mixed amphetamine salts than to methylphenidate have unique EEG profiles?
The investigators will measure brain activity before the participating children have tried any stimulant medications, and then again after a 3-week trial of Concerta (methylphenidate). Participants who do not show significant symptom improvement on Concerta will then complete a 3-week trial of Adderall (mixed amphetamine salts), and the study will measure brain activity while those children are on the best dose of Adderall. The investigators will collect information from the child, caregivers, and teachers each week to measure ADHD symptom improvement and side effects. This study will therefore follow the typical treatment approach used in the Boston Children's Hospital Developmental Medicine Clinic, but the investigators will add measures of brain functioning before and after medication.

Start Date17 Feb 2023

Sponsor / Collaborator

The Children's Hospital Corp.

100 Clinical Results associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

100 Translational Medicine associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

100 Patents (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

260

Literatures (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

27 Mar 2025·Cureus Journal of Medical Science

A Case Report: Lisdexamfetamine-Induced Delusional Parasitosis

Article

Author: Kelsey, John ; Chen, Xialing Ann

Attention-deficit hyperactivity disorder (ADHD) is generally treated with stimulant medications without significant complications. Delusional parasitosis (Ekbom syndrome) can occur secondary to ADHD treatment. It is a rare condition defined as having a fixed, false belief that one is infected with insects, parasites, or organisms and that one experiences cutaneous sensations without any clinical evidence of infestation. Although stimulant treatment with methylphenidate or mixed amphetamine salts has been associated with delusional parasitosis, there is yet a case in the literature illustrating delusional infestation secondary to lisdexamfetamine. The following case is unique in that lisdexamfetamine caused delusional parasitosis in a 53-year-old man with ADHD who previously tolerated mixed amphetamine salts and armodafinil without side effects. The discontinuation of lisdexamfetamine, coupled with a second-generation antipsychotic, quickly resolved the delusion. For those who may prescribe lisdexamfetamine or treat patients with ADHD, it is crucial to carefully assess medication use, as discontinuation or dose adjustment of the suspected causative drug can have a positive impact on the course of delusional parasitosis.

18 Mar 2025·Cureus Journal of Medical Science

The Cultural Perception of Abuse in a Multicultural Context and Its Impact on Mental Health: A Case Report

Article

Author: Gentry, Bryce ; Leggett, Richard ; Linder, Ellis ; Rashid, Mishalle F ; Grzybowska, Aleksandra

This case report reviews the psychiatric difficulties of a 27-year-old female patient from Botswana with symptoms fitting for posttraumatic stress disorder (PTSD), cluster B personality traits, and attention-deficit/hyperactivity disorder (ADHD). Her case illustrates how corporal punishment, an accepted practice in Botswana, remains in stark contrast to the standards of American society and the psychological consequences that may emerge from such practices. The patient presented with mood instability, anxiety, and recurrent depressive episodes, which were worsened by poor coping mechanisms including binge drinking and emotional dissociation. The patient's interviews confirmed the presence of PTSD, ADHD, and personality disorder per diagnostic criteria in the DSM-5. She was treated with lamotrigine and Adderall XR, with trauma-informed group therapy and psychoeducation about cultural perceptions of abuse. The patient showed improvement in emotional regulation and investment in the treatment; however, she continued to have difficulties with sleep hygiene and alcohol consumption. This case underlines the importance of culturally sensitive psychiatric care and emphasizes that osteopathic practitioners should further work within the framework of the trauma-informed approach with consideration of cultural influence when managing patients, especially those of migrant backgrounds.

01 Nov 2024·ADDICTIVE BEHAVIORS

Psychosocial stressors of adolescents with E-cigarette, or vaping, product-use associated lung injury: A qualitative study

Article

Author: Lee, Harin ; Harrell, Melissa B ; Rao, Devika R

BACKGROUND AND OBJECTIVES:

Adolescent electronic cigarette (EC) use has reached epidemic rates and has been linked to numerous mental health and psychosocial stressors (PS). There is limited qualitative data on PS for adolescents with e-cigarette, or vaping, product-use associated lung injury (EVALI), a severe complication of EC use.

METHODS:

All patients hospitalized at Children's Medical Center in Dallas, Texas from 2018 to 2022 and met CDC case definitions for EVALI were included in the analysis. PS were extracted from the electronic health record and analyzed for recurring themes using the HEADSS assessment as a framework. Results were summarized using descriptive statistics, and representative quotations were selected to highlight each theme.

RESULTS:

Forty-three adolescents (mean age 16.3 years; 62.8 % male; 39.5 % Non-Hispanic White, 60.5 % Hispanic) were included in the analysis, and 40 (93 %) reported PS. The most common themes were family (51 %; "restraining order issued against 28-year-old brother"), polysubstance use (77 %; "experimenting with…ecstasy, LSD, CCC, misusing Adderall"), and mental health (63 %; "has been suicidal since he was 'a toddler'"). Less commonly, patients reported PS related to peers (28 %; "spending the entire day at the cemetery where his best friend was buried"), school (49 %; "attending his second alternative school"), and the legal system (19 %; "placed in juvenile detention, released, and will be on probation").

CONCLUSIONS:

Adolescents with EVALI had PS that were chronic, severe, and involving multiple domains. These findings emphasize the importance of psychosocial screening in adolescents and coordinating interdisciplinary care with mental health and social services.

131

News (Medical) associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

20 May 2025

·www.prnewswire.com

Federal Indictment Against NJ Doctor Collapses in Stunning DOJ Reversal, as Obtained by Health Law Alliance

Prosecutors Dismiss All Charges in Nation's Last-Remaining Insys Prosecution SHORT HILLS, N.J., May 20, 2025 /PRNewswire/ -- The U.S. Department of Justice has dismissed all federal criminal charges against prominent New Jersey urologist Dr. Mukaram Gazi, who had been charged with accepting more than $130,000 in bribes from Insys Therapeutics in exchange for prescribing Subsys, a fentanyl-based medication, and unlawful distribution of controlled substances, including Adderall. The four-count indictment, which was part of a broader federal and state initiative targeting opioid-related misconduct, was dismissed in its entirety, with no plea agreement, no financial penalties, and no admission of guilt. All charges were dropped, including healthcare fraud, anti-kickback violations, and violations of the Controlled Substances Act. As a result of the dismissal, Dr. Gazi is the only individual among 35 individuals prosecuted for Insys-related offenses since 2014 to be exonerated. The victory was secured by Anthony Mahajan, a former federal prosecutor and now the founding partner of Health Law Alliance, a boutique law firm that specializes in defending healthcare professionals in complex civil, regulatory, and criminal matters. "This type of outcome is uncommon in federal healthcare prosecutions," noted a legal observer familiar with criminal cases involving medical professionals. The indictment, announced in November 2021, connected Dr. Gazi to Insys, whose executives, including founder John Kapoor, were convicted for unlawfully promoting Subsys for use in patients outside the FDA-approved label. However, the evidence in the case ultimately failed to support the accusations against Dr. Gazi, prompting federal prosecutors to dismiss the case shortly before trial. Dr. Gazi's defense relied, in part, on the authority given physicians under the law to prescribe drugs "off label" for the advancement of medicine and patient care. The law also permits doctors to be compensated appropriately by pharmaceutical and medical device companies for participating in "speaker programs" and other educational activities. The dismissal underscores the importance of prosecutorial restraint in complex medical cases, particularly where criminal prosecution may chill lawful behavior and inhibit patient care. For more information, contact Health Law Alliance at (800) 345-4125 or [email protected]. SOURCE Health Law Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

15 May 2025

·www.prnewswire.com

Clearwater Periodontist Warns About Medications and Dry Mouth: The Hidden Threat to Oral Health

CLEARWATER, Fla., May 15, 2025 /PRNewswire/ -- Dr. Todd M. Britten, a trusted periodontist in Clearwater, is raising awareness about a critical but often overlooked issue for patients taking medications for ADHD, depression, anxiety, and other psychiatric conditions – dry mouth, also known as xerostomia. This common side effect can lead to severe oral health complications, including periodontal disease, cavities, burning mouth syndrome, and oral thrush. Dr. Britten emphasizes the importance of understanding these risks and taking proactive steps to protect oral health while on these medications. Continue Reading View PDF The Connection Between Medications and Dry Mouth Many medications, particularly those prescribed for mental health conditions, are known to decrease saliva production. These medications include: Stimulants (e.g., Adderall), commonly used to treat ADHD, can cause dehydration and dry mouth. Antidepressants, such as SSRIs, tricyclics, and MAOIs, are linked to reduced saliva flow. Anxiety Medications, including benzodiazepines, have a drying effect on the mouth. Psychotropic Drugs, prescribed for conditions like schizophrenia and bipolar disorder, often lead to significant decreases in saliva production. Oral Health Complications Linked to Dry Mouth Saliva is essential for maintaining healthy teeth and gums. When its flow is reduced, it can contribute to several dental problems: Periodontal Disease: Reduced saliva creates an environment where bacteria can thrive, leading to gingivitis and periodontitis. Dental Caries (Cavities): The lack of saliva increases the risk of tooth decay, especially along the gumline and between teeth. Burning Mouth Syndrome: A burning sensation in the mouth can develop, particularly in those taking psychotropic medications. Candidiasis (Oral Thrush): Without enough saliva, fungal infections can become more common, causing discomfort and oral sores. Preventive Measures to Protect Oral Health To minimize the effects of dry mouth, Dr. Britten advises patients to implement the following strategies: Stay Hydrated: Drink plenty of water throughout the day to maintain moisture in the mouth. Use Saliva Substitutes: Artificial saliva products or sugar-free gum with xylitol can help stimulate saliva production. Maintain Good Oral Hygiene: Brush twice daily with fluoride toothpaste and floss regularly to reduce plaque buildup. Regular Dental Checkups: Schedule regular dental visits for professional cleanings and fluoride treatments. Avoid Alcohol and Caffeine: These substances can further dry out the mouth, so limiting consumption is recommended. Consult with Your Physician: If possible, work with your doctor to adjust medications or explore alternatives that may not have the same drying effects. Conclusion Dr. Todd M. Britten is urging patients who take medications that can cause dry mouth to take proactive steps in protecting their oral health. By understanding the risks and implementing preventive measures, patients can reduce the impact of dry mouth and maintain their oral hygiene. For those on long-term psychiatric medications, it's crucial to consult with both dental and medical professionals to ensure proper management of these side effects. About Dr. Todd M. Britten, DMD Dr. Todd M. Britten is a board-certified periodontist based in Clearwater, FL, specializing in advanced dental care and periodontal treatments. With a commitment to patient education and comprehensive care, Dr. Britten has helped countless patients maintain optimal oral health throughout their lives. SOURCE Todd M Britten, DMD, LLC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

16 Apr 2025

·www.prnewswire.com

Glenmark Pharmaceuticals Inc., USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg

MAHWAH, N.J., April 16, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch[1] of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is bioequivalent and therapeutically equivalent to the reference listed drug, Adderall®[2] Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women's Health, Inc. and the company will begin distribution in May 2025. According to IQVIA™ sales data for the 12-month period ending February 2025, the Adderall® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market[3] achieved annual sales of approximately $421.7 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is a highly prescribed medication in the United States. Glenmark is very pleased to be able to help alleviate the shortage this country has been facing with this upcoming launch." About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of cardio-metabolic, respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions. For more information, visit . You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). References: 1. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is only approved for the indication(s) listed in Glenmark's approved label. 2. All brand names and trademarks are the property of their respective owners. 3. Market includes brand and all available therapeutic equivalents. Note: IQVIA data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications. *IQVIA™ National Sales Perspectives: Retail & Non-Retail, February 2025. Logo: For more information, please contact: Udaykumar Murthy [email protected] +91 9960377617 SOURCE Glenmark Pharmaceuticals Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

100 Deals associated with Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetamine Sulfate	-	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Teva Women's Health, Inc.	19 Jan 1960

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03945175 (MYDAYIS, CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	52	Placebo	bxywjogmvj(ygnqcxarci) = xvgfozlmgj dpqvusilnq (uctocxcuna, 11.4) View more	-	29 Jun 2023
NCT03810703 (HAP, CTgov)	Phase 1	Bipolar II disorder	93	Placebo oral capsule (Placebo Arm)	ozxglvorhf(fnbfdygxgk) = nggpdcdztz yyrqmcsmld (lltvdafucz, 8.84) View more	-	22 Feb 2023
				d-amphetamine (Amphetamine 10 mg Arm)	ozxglvorhf(fnbfdygxgk) = camhxkcmqa yyrqmcsmld (lltvdafucz, 4.46) View more
NCT02803229 (MJ-ADHD, CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity \| Cannabis withdrawal	33	Matched placebo (Placebo)	rlambidzfp = dbvnyyjfve yiiurqnxxl (dmejavfvra, zkwanqmalk - edhlwfuubd) View more	-	09 Apr 2021
				Adderall-XR (Adderall-XR)	rlambidzfp = ipnjfswvnr yiiurqnxxl (dmejavfvra, vhwwaquamf - grdbdqmida) View more
NCT03325881 (Pubmed) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	89	SHP465 MAS	nrohvbmkyj(fhmqohofoo): difference = -1.9 (95% CI, -6.8 to 3.1), P-Value = 0.451 View more	Negative	01 Nov 2020
				Placebo
NCT03325894 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	141	SHP465-112+SHP465 (Group A (Antecedent Studies))	ylgdrvcyyc = niedbjdtav owkloosnnl (zhvvluylwq, qggmzfrsnh - mpdmpdaznb) View more	-	05 Feb 2020
				SHP465 (Group B (Direct Enrollment))	ylgdrvcyyc = wcrmfgnjak owkloosnnl (zhvvluylwq, xcdminjmzb - tttbjkaypj) View more
NCT03327402 (CTgov)	Phase 1	Attention Deficit Disorder With Hyperactivity	24	SHP465	skwpxcdvwe(eejtdigojh) = otwyoucbev upcbdkzdat (yfkluswdfk, 32.6) View more	-	29 Jan 2020
NCT03530631 (CTgov)	Phase 4	-	4	Adderall (Adderall/Truth)	tupsvxbgcw = akkeimqckx zejjjcgldd (yulrjblouh, bjzqgjngdt - rgbdcdoyft) View more	-	14 Oct 2019
				Placebo (Placebo/Truth)	tupsvxbgcw = zjwozvotbe zejjjcgldd (yulrjblouh, bisstumyev - hemxipxpaf) View more
NCT03325881 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	89	Placebo (Placebo)	taxixftjpn(kbqpmjzlpa) = cowcmghxnn vhrqpynexx (cemolzrwzo, cwfcsndixj - ywlvssttsi) View more	-	13 Aug 2019
				SHP465 (SHP465)	taxixftjpn(kbqpmjzlpa) = auzccpzmmu vhrqpynexx (cemolzrwzo, fzkaiycfht - zvawlqppbs) View more
NCT02466425 (Pubmed \| J Child Adolesc Psychopharmacol) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	264	SHP465 MAS	vmuipmkooo(imkxzarodx): difference = -9.9 (95% CI, -13.0 to -6.8), P-Value = <0.001 View more	Positive	01 Feb 2018
				Placebo

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