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

NCT06853665

/ Not yet recruitingPhase 2IIT

A Pharmaco-Imaging Trial of Mixed Amphetamine Salts for the Treatment of ADHD in Intellectually-intact Youth with Autism Spectrum Disorder

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 May 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

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

18 Mar 2025·Cureus

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

Article

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

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

BACKGROUND AND OBJECTIVESAdolescent 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.METHODSAll 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.RESULTSForty-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").CONCLUSIONSAdolescents 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.

01 May 2024·Bipolar Disorders

Efficacy and safety of established and off‐label ADHD drug therapies for cognitive impairment or attention‐deficit hyperactivity disorder symptoms in bipolar disorder: A systematic review by the ISBD Targeting Cognition Task Force

Review

Author: Balanzá‐Martínez, Vicent ; Young, Allan H. ; López‐Jaramillo, Carlos ; Kessing, Lars V. ; Gallagher, Peter ; Torres, Ivan J. ; Yatham, Lakshmi N. ; Sumiyoshi, Tomiki ; Douglas, Katie ; Miskowiak, Kamilla W. ; Obel, Zacharias K. ; Stokes, Paul R. A. ; Lewandowski, Kathryn E. ; Guglielmo, Riccardo ; McIntyre, Roger S. ; Purdon, Scot E. ; Martinez‐Aran, Anabel ; Dols, Annemieke ; Vieta, Eduard ; Burdick, Katherine E. ; Bowie, Christopher R. ; Hasler, Gregor ; Porter, Richard J. ; Schaffer, Ayal ; Bonnin, Caterina del Mar ; Van Rheenen, Tamsyn E. ; Carvalho, Andre F. ; Lafer, Beny

AbstractBackgroundAbnormalities in dopamine and norepinephrine signaling are implicated in cognitive impairments in bipolar disorder (BD) and attention‐deficit hyperactivity disorder (ADHD). This systematic review by the ISBD Targeting Cognition Task Force therefore aimed to investigate the possible benefits on cognition and/or ADHD symptoms and safety of established and off‐label ADHD therapies in BD.MethodsWe included studies of ADHD medications in BD patients, which involved cognitive and/or safety measures. We followed the procedures of the Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) 2020 statement. Searches were conducted on PubMed, Embase and PsycINFO from inception until June 2023. Two authors reviewed the studies independently using the Revised Cochrane Collaboration's Risk of Bias tool for Randomized trials.ResultsSeventeen studies were identified (N = 2136), investigating armodafinil (k = 4, N = 1581), methylphenidate (k = 4, N = 84), bupropion (k = 4, n = 249), clonidine (k = 1, n = 70), lisdexamphetamine (k = 1, n = 25), mixed amphetamine salts (k = 1, n = 30), or modafinil (k = 2, n = 97). Three studies investigated cognition, four ADHD symptoms, and 10 the safety. Three studies found treatment‐related ADHD symptom reduction: two involved methylphenidate and one amphetamine salts. One study found a trend towards pro‐cognitive effects of modafinil on some cognitive domains. No increased risk of (hypo)mania was observed. Five studies had low risk of bias, eleven a moderate risk, and one a serious risk of bias.ConclusionsMethylphenidate or mixed amphetamine salts may improve ADHD symptoms in BD. However, there is limited evidence regarding the effectiveness on cognition. The medications produced no increased mania risk when used alongside mood stabilizers. Further robust studies are needed to assess cognition in BD patients receiving psychostimulant treatment alongside mood stabilizers.

127

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

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

12 Mar 2025

·www.drugs.com

More Children Accidentally Poisoned By Fentanyl

WEDNESDAY, March 12, 2025 -- The number of children poisoned through exposure to fentanyl , a powerful synthetic opioid, has skyrocketed in recent years, researchers have reported. Fentanyl poisonings increased by 924% among children 12 and younger between 2015 and 2023, and by 1,506% among teens 13 to 19, researchers reported March 8 in the American Journal of Drug and Alcohol Abuse . In 2023 alone, 45% of the poisonings were life-threatening incidents in which kids could have died without prompt treatment, up from 16% of cases in 2015. “We can’t forget that kids are also at risk during this opioid crisis,” said lead researcher Joseph Palamar , an associate professor of population health at the NYU Grossman School of Medicine in New York City. “Parents and others need to be careful to not leave fentanyl, whether licit or illicit, out in the open around unsupervised children,” he said in a news release. “Even second-hand exposure to paraphernalia or baggies can contain small amounts of fentanyl [that] can be lethal to youngsters.” For the study, researchers reviewed calls and reports made to U.S. poison control centers in 49 U.S. states between 2015 and 2023. More than 3,000 fentanyl poisonings among children 19 and younger were reported to poison control centers during that period, researchers explained. About 59% of the poisonings occurred in teenagers, with 41% happening involving kids 12 and younger. Boys accounted for 59% of fentanyl poisonings, researchers said. About 82% of poisonings among children 12 and younger were unintentional, results show. On the other hand, 66% of 13- to 19-year-olds were using fentanyl to get high when they were poisoned, researchers found. These results show that the U.S. continues to battle a severe opioid crisis fueled by fentanyl use, researchers said. Counterfeit pills containing fentanyl have flooded the illicit market, researchers said in background notes. In recent years, 7 of 10 counterfeit pills seized have contained a potentially deadly amount of fentanyl. “Parents need to be aware that teens can purchase pills via apps that are sold as Adderall or Xanax but actually contain fentanyl,” Palamar said. “Children may touch or ingest such items out of curiosity, through a lack of a sense of danger, or even imitation of a parent who uses,” he added. “Even used fentanyl patches can lead to accidental or intentional poisonings among pediatric populations.” Senior researcher Joshua Black , a senior scientist at Rocky Mountain Poison & Drug Safety in Colorado, said parents should keep naloxone on hand to counter any accidental overdose that might occur from fentanyl or another opioid. “Parents and peers need to be able to promptly detect signs and symptoms of opioid overdose — including looking pale, slow or no breathing, coma, sometimes constricted pupils — and know when to seek help,” Black said. “We encourage people to contact a poison center if they suspect a poisoning (1-800-222-1222) or call 911 if someone collapses, has a seizure, has trouble breathing or can’t be awakened following drug use,” Black concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

04 Mar 2025

·www.fiercepharma.com

Glenmark issues another recall, this time for nearly 1.5M bottles of generic ADHD drug

Glenmark Pharma is recalling nearly 1.5 million bottles of the attention-deficit/hyperactivity disorder drug atomoxetin. Glenmark Pharma, an India-based drug manufacturer that has been the focal point of a spate of recalls in recent years, has issued another. This time, the product pull covers about 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine.Eli Lilly previously sold the branded version of the drug, Strattera, but discontinued all strengths in 2023 after the arrival of generics.Unlike stimulant-based drugs that make up the bulk of ADHD treatment, including those like Vyvanse and Adderall, atomoxetine is a selective norepinephrine reuptake inhibitor (sNRI).The recall was triggered by the presence of unacceptable levels of N-nitroso atomoxetine, a possible carcinogen, in multiple Glenmark atomoxetine batches, according to the FDA. The voluntary pull, which began Jan. 29, covers bottles of the drug in strengths ranging from 10 mg to 100 mg, the FDA said on its Enforcement Report webpage. The ADHD drugs were manufactured in Glenmark’s facility in Goa, India, and were distributed nationwide. Glenmark has weathered a string of recalls in recent years due to both manufacturing and labelling issues.In June 2024, the company recalled 114 batches of 750 mg potassium chloride extended-release capsules—or roughly 47 million capsules—over concerns that they failed to dissolve properly.In December, the company recalled 90,528 bottles of the high blood pressure drug diltiazem hydrochloride in tablet and extended-release forms due to unacceptable levels of another N-nitroso compound, N-nitroso-Desmethyl-Diltiazem.In separate actions in 2023, Glemark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets used to treat high blood pressure; 37,200 bottles of Indomethacin, which is a non-steroidal anti-inflammatory used to treat pain and arthritis symptoms; and five lots (no bottle count provided) of Naproxen that is used to reduce fever or relieve mild pain.The previous year it recalled 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion that treats skin conditions such as eczema, psoriasis, allergies and rash.

Clinical Result

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

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Takeda Pharmaceuticals U.S.A., Inc.	11 Oct 2001

Developing

10 top R&D records.

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03810703 (HAP, CTgov)	Phase 1	Bipolar II disorder	93	Placebo oral capsule (Placebo Arm)	tqjxeucuzf(flrucwtpgi) = ynezqqpurx sbfgbufply (sacipfstiz, kowaurciox - pvpndkbrti) View more	-	22 Feb 2023
				d-amphetamine (Amphetamine 10 mg Arm)	tqjxeucuzf(flrucwtpgi) = yzkktqvgmy sbfgbufply (sacipfstiz, gukawuvtlj - htipuzhsqv) View more
NCT02803229 (MJ-ADHD, CTgov)	Phase 2/3	Marijuana Abuse \| Attention Deficit Disorder With Hyperactivity	33	Matched placebo (Placebo)	cutvmgyocl(lojegwogvz) = bqgxvrkjgv gftbmlewkb (wblpdgvjpg, tcjqlmqxrd - sjqblenapv) View more	-	09 Apr 2021
				Adderall-XR (Adderall-XR)	cutvmgyocl(lojegwogvz) = igrrouxfaa gftbmlewkb (wblpdgvjpg, ogkrjlwxkl - vbqwxgbjse) View more
NCT03325894 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	141	SHP465-112+SHP465 (Group A (Antecedent Studies))	nciknkhxqw(foawnzvjbt) = qhdhjyhvsp ijqbvtqent (hukkedwgjv, jgrwqcwfaa - iqzjgsprfx) View more	-	05 Feb 2020
				SHP465 (Group B (Direct Enrollment))	nciknkhxqw(foawnzvjbt) = xnodacnckl ijqbvtqent (hukkedwgjv, shpnnobbcn - rcyqpffqro) View more
NCT03327402 (CTgov)	Phase 1	Attention Deficit Disorder With Hyperactivity	24	SHP465	iyszbwaocu(ytwjjhyxfv) = nrynxsufpc lffvvuuvjr (ajsgznjrwp, aqsqipybvr - ujvwhgqrvv) View more	-	29 Jan 2020
NCT03530631 (CTgov)	Phase 4	-	4	Adderall (Adderall/Truth)	xborasujzr(dqbqlojvyw) = qfvbcewvtb yrthpdcsvu (yvyretnmwy, lhbhjrzdab - upebztrqxi) View more	-	14 Oct 2019
				Placebo (Placebo/Truth)	xborasujzr(dqbqlojvyw) = caqwthwikp yrthpdcsvu (yvyretnmwy, dvbaqnsvne - btfqhlfgjt) View more
NCT03325881 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	89	Placebo (Placebo)	vrwrtuhjfy(xzudseaqdv) = dquxepigjk wlgwkknipz (kehicbumlx, bewrljiutm - eaxfocbujr) View more	-	13 Aug 2019
				SHP465 (SHP465)	vrwrtuhjfy(xzudseaqdv) = fywsihslht wlgwkknipz (kehicbumlx, bscymxwskx - zymjrquvxd) View more
NCT02466425 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	264	Placebo (Placebo)	vbzbgcbmrz(rsluronkmb) = kgowmnuctw hfhacubaeq (asjqmimyob, iqkuwlubrn - dedbkzltjk) View more	-	20 Mar 2017
				SHP465 (SHP465)	vbzbgcbmrz(rsluronkmb) = dqptenmkqd hfhacubaeq (asjqmimyob, wpzsxgsmfv - badggividr) View more
ASN2014	Not Applicable	Seizures \| Hyponatremia	-	Adderall	efxgpmkgwi(rhhkfogeju) = experienced a witnessed seizure-like episode iffslwjhin (hnnsltlfgq ) View more	-	11 Nov 2014
				Normal saline
NCT00553319 (CAMP, CTgov)	Phase 2/3	Cocaine-Related Disorders \| Attention Deficit Disorder With Hyperactivity	139	Placebo (Placebo)	jbquqjjlwv(flxbtluhkz) = jguhwnzhqn jmgabxzxzw (tuqzcgyynz, izgfmzwivu - ijwkbrvrvm) View more	-	01 Sep 2014
				Adderall-XR (Adderall-XR 60 mg)	jbquqjjlwv(flxbtluhkz) = pfquyktmwt jmgabxzxzw (tuqzcgyynz, nmcnzfuxxn - axluqvzzcb) View more

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