dexamphetamine ER (PFR08001) / Ensysce Biosciences - LARVOL DELTA

A double-blind randomised controlled trial protocol comparing dexamphetamine and placebo effectiveness for obesity management in primary care settings. (PubMed, MethodsX) - "Participants are randomised 1:1 to receive either dexamphetamine or placebo, starting at 5 mg twice daily, with weekly titration up to 30 mg twice daily as tolerated. Dose adjustments are guided by clinical effects and a standardised amphetamine rating scale, with gradual down-titration during the final month. If demonstrated to be effective and safe long-term, dexamphetamine could provide a scalable, practical solution to reduce the individual and societal burden of obesity."

Journal • Genetic Disorders • Obesity

Stimulant prescription for ADHD in people with a past history of anorexia nervosa. (PubMed, Australas Psychiatry) - "This did not appear to exacerbate AN-pathology. Patients experienced subjective improvement in ADHD pathology, attenuation of the negative impacts of ADHD on AN, and subjective improvements in anxiety, depression, and suicidality.ConclusionThese preliminary findings indicate safety and acceptability for the careful use of stimulants in people with ADHD and a history of AN and paves the way for larger studies to demonstrate clinical benefit."

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

Characterisation of the pharmacodynamic effects of the P2X7 receptor antagonist JNJ-54175446 using an oral dexamphetamine challenge model in healthy males in a randomised, double-blind, placebo-controlled, multiple ascending dose trial. (PubMed, J Psychopharmacol) - "Subjects (N = 64) were randomised to either JNJ-54175446 (50-450 mg; n = 48) or placebo (n = 16) and underwent a baseline oral 20 mg dexamphetamine challenge followed by 11 consecutive days q.d. dosing with JNJ-54175446/placebo and a randomised crossover dexamphetamine/placebo challenge. At doses ⩾100 mg, JNJ-54175446 attenuated dexamphetamine-induced increases in locomotion and enhanced the mood-elevating effects of dexamphetamine, suggesting that a dose that is approximately twice as high is needed to obtain a central PD response compared to the dose needed for maximum peripheral occupancy. Overall, the observed pharmacological profile of JNJ-54175446 in the dexamphetamine challenge paradigm is compatible with a potential mood-modulating effect."

Clinical • Journal • PK/PD data

Setting the beat of an internal clock: Effects of dexamphetamine on different interval ranges of temporal processing in healthy volunteers. (PubMed, Psych J) - "These findings indicate that the dexamphetamine-induced increase in the speed of the internal pacemaker was modulated by the basal working memory capacity of each participant. These findings in healthy humans have important implications for the role of dopamine, and its contributions to timing deficits, in models of psychiatric disorders."

Clinical • Journal