lisdexamfetamine / Generic mfg. - LARVOL DELTA

Bioactivation and Metabolism of Amino Acid MDMA Prodrugs in Zebrafish Embryos, Human Liver S9, Whole Blood, and Microdosed Human Urine. (PubMed, Drug Test Anal) - "Like lisdexamfetamine, amino acid prodrugs of MDMA may enable more controlled systemic exposure, but their metabolic activation pathways and metabolites are not known yet...This study demonstrated conversion of amino acid prodrugs to MDMA in pHLS9- and ZE-based systems and in humans after microdosing, but not in blood. There is a need for further studies such as their pharmacokinetic profiles in humans."

Journal

Safety and Effectiveness of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD in Japan: An Interim Analysis of Post-Marketing Surveillance. (PubMed, Adv Ther) - "No ADRs requiring new safety measures were observed. The effectiveness of LDX was confirmed in real-world practice. This study is ongoing, and the final results will be reported upon completion."

Journal • P4 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Endocrine Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder

COST OF ADVERSE EVENT MANAGEMENT IN CHILDREN, ADOLESCENTS, AND ADULTS WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER IN THE UNITED STATES (ISPOR 2026) - "Pairwise comparisons were conducted between centanafadine and each of lisdexamfetamine dimesylate, atomoxetine hydrochloride, viloxazine, methylphenidate hydrochloride, and guanfacine in children and adolescents, and each of lisdexamfetamine dimesylate, atomoxetine hydrochloride, viloxazine, and methylphenidate hydrochloride in adults. Centanafadine has the potential to reduce AE-related healthcare costs compared with alternative ADHD therapies for children, adolescents, and adults."

Adverse events • Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

LAMAinDiab: Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Medical University of Lodz | Active, not recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Diabetes • Metabolic Disorders • Pediatrics • Psychiatry • Type 1 Diabetes Mellitus

Pharmacogenetic Considerations in Sertraline Augmentation With Quetiapine in an Adolescent Woman With Obsessive-Compulsive Disorder, Autism Spectrum Disorder, and Attention-Deficit Hyperactivity Disorder: A Case Report. (PubMed, Cureus) - "She had previously been stabilised on sertraline (200 mg) and lisdexamfetamine (60 mg). This case highlights the complexities of psychological and pharmacological management of OCD in the context of neurodevelopmental comorbidity. Improved understanding of precision psychiatry in OCD with ASD comorbidity may facilitate the development of more tailored treatment approaches, including neurodevelopmentally adapted psychological interventions and targeted pharmacological strategies."

Biomarker • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry • Suicidal Ideation

LISDE-01-25: An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with VENVANSE (lisdexamfetamine dimesylate) 70 mg Hard Gelatin Capsule, imported and registered by: Takeda Pharma Ltd. Rodovia SP 340 S/N, km... (clinicaltrialsregister.eu) - P1 | N=54 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • CNS Disorders • Psychiatry

Psychotherapy-Supported Lisdexamfetamine Tapering in Binge-Eating Disorder: Spotlighting a Critical Research Gap. (PubMed, Int J Eat Disord) - "This spotlight highlights the need for further research to investigate discontinuing LDX and whether gradual, therapist-supported tapering might enable the superiority of combined treatment to be sustained. Spotlighted examples were used to illustrate the conceptual framework and clinical relevance of this spotlight's central argument: that systematically evaluating optimal approaches to medication discontinuation, specifically LDX for BED, is an idea worth researching. We describe potential obstacles and limitations while also highlighting clinical or policy implications for future study."

Journal • Binge Eating Disorder • Cardiovascular • CNS Disorders • Hypertension • Psychiatry

Pharmacological management of attention deficit hyperactivity disorder in adults. (PubMed, Aust Prescr) - "The main pharmacotherapies for adults with ADHD include psychostimulants, such as methylphenidate and amphetamines (dexamfetamine and lisdexamfetamine), and non-psychostimulants such as atomoxetine. Individuals prescribed ADHD drugs should be monitored for both physical (e.g. cardiac symptoms, appetite changes, seizures) and psychiatric (e.g. mood disturbances, anxiety, psychosis) adverse effects. While pharmacological treatment is effective for adults with ADHD, it should be integrated into a broader, multidisciplinary approach that also includes nonpharmacological strategies such as psychological therapies and allied health support."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Developmental Disorders • Epilepsy • Mood Disorders • Psychiatry

Glutamatergic Enhancement Using As-Needed Dextromethorphan and Piracetam in a Stimulant-Partially Responsive Adult With ADHD: A Single-Case Report. (PubMed, Cureus) - "Emerging evidence points to disrupted dopamine-glutamate coupling and insufficient synaptic pruning as contributors to these persistent deficits, suggesting a potential role for glutamatergic modulation inspired by ketamine's rapid neuroplastic effects. This report describes a 25-year-old man with childhood-onset ADHD who, despite trials of high-dose methylphenidate (up to 72 mg) and lisdexamfetamine (up to 80 mg), continued to report daytime lethargy, mental sluggishness, irritability, and oversleeping while on moderate-dose extended-release methylphenidate (Concerta 36-54 mg daily)...This single-case observation suggests that low-dose dextromethorphan, through brief N-methyl-D-aspartate modulation, combined with piracetam's α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) potentiation, may enhance methylphenidate's modest glutamate release, potentially promoting an AMPA-favorable plasticity state that could help mitigate pruning-related..."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Psychiatry

Innovative Pharmacological Approaches to Eating Disorder Treatment. (PubMed, Psychiatr Clin North Am) - "Stimulants like lisdexamfetamine offer benefits for binge-eating disorder, while medications for avoidant/restrictive food intake disorder and bulimia nervosa remain understudied. The study underscores the need for robust clinical trials to evaluate these approaches and advocates for integrating novel treatments into existing therapeutic frameworks to address the complex biological and psychological dimensions of eating disorders."

Journal • Review • Anorexia • Binge Eating Disorder • Bulimia • CNS Disorders

A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Pharmacological manipulation of binge-like eating in male and female rats. (PubMed, Pharmacol Biochem Behav) - "The amphetamine prodrug lisdexamfetamine (0.1875-1.5 mg/kg IP), which is used to treat binge eating disorder in humans, suppressed intake of all foods in both sexes, with the greatest effects on chocolate. Co-administration of dopamine receptor antagonists with varying selectivity profiles (ecopipam, haloperidol, flupenthixol) reversed the suppressive effects of LDX on binge-like intake of chocolate, with haloperidol and flupenthixol producing more robust effects. The final group of studies characterized the effects of two commonly prescribed drugs for weight-loss that have been suggested as treatment options for binge eating disorder (bupropion and naltrexone). These drugs, alone and in combination, suppressed binge-like intake of chocolate. Taken together, these findings contribute to the development of animal models of BLE, which can potentially foster the development of treatments for binge eating disorder."

Journal • Preclinical • Binge Eating Disorder • CNS Disorders

Trends in use of Attention-Deficit Hyperactivity Disorder medications among children and adults in five European countries, 2010 to 2023: a population-based observational study. (PubMed, Lancet Reg Health Eur) - "We estimated the prevalence and incidence of methylphenidate, dexamphetamine, lisdexamfetamine, atomoxetine and guanfacine use among individuals aged 3 years and older. Understanding the utilisation of ADHD medications can provide useful information in monitoring use, as well as for anticipation and planning to minimise potential shortages. European Medicines Agency."

Journal • Observational data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (clinicaltrials.gov) - P2/3 | N=60 | Active, not recruiting | Sponsor: Yale University | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Complications Associated With the Switch From Brand to Generic Lisdexamfetamine: Two Patient Cases. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal

Medication Adherence in Children and Adults Receiving Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Sweden: A Nationwide Study. (PubMed, J Atten Disord) - "The overall rates of treatment adherence are high for children and adults receiving ADHD medication in Sweden. We observed lower adherence among adolescents, which warrants further study."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Vyvanse in Children Aged 6 to 12 Years (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: University of Minnesota | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

New P1 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Effectiveness of Pharmacological Treatments for Adult ADHD on Psychiatric Comorbidity: A Systematic Review. (PubMed, J Clin Med) - "This systematic review evaluated the effectiveness of commonly prescribed medications for adult ADHD (methylphenidate, atomoxetine, bupropion, and lisdexamfetamine) on comorbid mood, anxiety, personality, and substance use disorders. Tricyclic antidepressants were also included in the search strategy; however, no eligible adult studies assessing imipramine or desipramine in patients with ADHD and psychiatric comorbidity were identified...While targeted improvements may occur in specific domains, the evidence base is insufficient to define optimal long-term strategies for adults with ADHD and complex comorbidity. Rigorous, longitudinal studies are needed to clarify medication effects on distinct comorbid profiles and to inform integrated treatment planning."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mood Disorders • Personality Disorder • Psychiatry

Efficacy of atomoxetine and oxybutynin in the treatment of pediatric obstructive sleep apnea, a three case report. (PubMed, Front Sleep) - "Of note, the first patient was concurrently treated with lisdexamfetamine for attention deficit hyperactivity disorder, while the second had morbid obesity under treatment with liraglutide. These cases suggest a potential role for atomoxetine and oxybutynin as alternative therapeutic options for pediatric OSA in complex scenarios where severe OSA persists despite AT and failed CPAP therapy, warranting further evaluation in large pediatric clinical trials. Nevertheless, the final case underscores that even pharmacological treatments, although seemingly straightforward to administer, may encounter adherence challenges."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Pediatrics • Psychiatry • Respiratory Diseases • Sleep Disorder

Reduction of Loss of Control Eating in Youth With Attention-Deficit/Hyperactivity Disorder Following Initiation of Stimulant Medication: A Prospective Study. (PubMed, J Clin Psychopharmacol) - "Findings provide preliminary support for a potential relationship between stimulant medication and reduced LOC-E and associated symptoms in youth with ADHD and comorbid LOC-E. Results mostly align with prior adult studies evaluating lisdexamfetamine for binge-eating disorder. Larger, controlled trials are needed to confirm these findings and investigate neurocognitive mechanisms. This study offers early evidence to inform future pharmacological approaches to treat ADHD and LOC-E in youth."

Journal • Observational data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • CNS Disorders • Cognitive Disorders • Mood Disorders • Psychiatry

Sexual Functioning in Individuals With Attention-Deficit Hyperactivity Disorder: A Narrative Review. (PubMed, Cureus) - "Some authors emphasize the importance of neurobiological mechanisms such as "dopaminergic craving" or novelty-seeking, while others indicate that hypersexual behaviors may be treated as a form of self-regulation. Concerning pharmacotherapy, psychostimulant drugs (e.g., methylphenidate and lisdexamfetamine) and nonstimulants (e.g., atomoxetine and clonidine) demonstrate both beneficial and adverse impacts on sexual functioning, although empirical data are limited. ADHD shows a significant correlation with the occurrence of a wide spectrum of sexual disorders, which requires consideration in diagnostics and treatment planning. The high prevalence of hypersexuality, CSBD, and RSD highlights the need for an interdisciplinary approach combining pharmacological interventions with psychotherapy focused on emotional regulation, improvement of interpersonal relationships, and reduction of risky behaviors. Further research..."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Behavior Disorders • CNS Disorders • Mental Retardation • Pediatrics • Psychiatry • Sexual Disorders

Efficacy, Safety and Tolerability of Lisdexamfetamine Dimesylate Treatment Compared With Placebo in Adults With Binge-Eating Disorder: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. (PubMed, Eur Eat Disord Rev) - "LDX demonstrates significant efficacy in reducing binge-eating behaviours and associated obsessive-compulsive symptoms in patients with BED, with a tolerable safety profile. These findings support the clinical use of LDX for managing BED."

Journal • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • CNS Disorders • Depression • Genetic Disorders • Mood Disorders • Obesity • Psychiatry

Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (clinicaltrials.gov) - P2 | N=440 | Recruiting | Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) | Trial completion date: Nov 2025 ➔ Apr 2028 | Trial primary completion date: Nov 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry

Insomnia is associated with psychological distress in individuals with methamphetamine dependence. (PubMed, Australas Psychiatry) - "This study examined the relationship between insomnia severity and psychological distress in treatment-seeking individuals with methamphetamine dependence.MethodsThis is a secondary cross-sectional analysis of baseline data from 152 participants enrolled in a randomised controlled trial of lisdexamfetamine versus placebo for methamphetamine dependence. In adjusted models, insomnia remained associated with distress: each 1-point ISI increase related to a 2.1-2.5% rise in DASS-21 depression and stress scores (β = 0.021-0.025, p = .003-.007), and a 6.5% increase in total scores (β = 0.063, p < .001); the association with anxiety was attenuated.ConclusionsOur study identified insomnia as an independent correlate of psychological distress in treatment-seeking individuals with methamphetamine dependence. Findings underscore sleep problems' relevance and support further research into sleep-focused interventions."

Journal • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder