Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2015
Dasotraline for the Treatment of Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults.
Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.
- Safety and efficacy of dasotraline for patients with attention deficit/hyperactivity disorder: a systematic review and meta-analysis of 1594 patients including GRADE qualifications.Psychopharmacology · 2025Pooled it
- Efficacy and safety of dasotraline in adults with binge-eating disorder: a randomized, placebo-controlled, fixed-dose clinical trial.CNS spectrums · 2021Trial
- Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study.Journal of attention disorders · 2020Trial
- Approved and Pipeline Pharmacological Interventions for Eating Disorders (2010-2025): 15 Years of Progress (or Lack Thereof).CNS drugs · 2026Review
- Structural basis for pharmacotherapeutic action of triple reuptake inhibitors.Nature communications · 2025Article
- Revisiting the Role of Serotonin in Attention-Deficit Hyperactivity Disorder: New Insights from Preclinical and Clinical Studies.Clinical drug investigation · 2025Review
- Unlocking the Potential of High-Quality Dopamine Transporter Pharmacological Data: Advancing Robust Machine Learning-Based QSAR Modeling.Advances in neurobiology · 2025Review
- Intermolecular Asymmetric Arylative Dearomatization of 1-Naphthols.Journal of the American Chemical Society · 2024Article
- Efficacy and safety of dasotraline in attention-deficit hyperactivity disorder: A systematic review and meta-analysis.Indian journal of psychiatry · 2024Review
- Adult attention deficit hyperactivity disorder: a comprehensive review.Annals of medicine and surgery (2012) · 2023Article
- Epilepsy and Attention Deficit Hyperactivity Disorder: Connection, Chance, and Challenges.International journal of molecular sciences · 2023Review
- Dopamine, Immunity, and Disease.Pharmacological reviews · 2023Review
- Prospects for new drugs to treat binge-eating disorder: Insights from psychopathology and neuropharmacology.Journal of psychopharmacology (Oxford, England) · 2022Review
- What pharmacological interventions are effective in binge-eating disorder? Insights from a critical evaluation of the evidence from clinical trials.International journal of obesity (2005) · 2022Review
- New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development.Current topics in behavioral neurosciences · 2022Review
- Converging vulnerability factors for compulsive food and drug use.Neuropharmacology · 2021Review
- Lifetime evolution of ADHD treatment.Journal of neural transmission (Vienna, Austria : 1996) · 2021Review
- Treatment strategies for ADHD: an evidence-based guide to select optimal treatment.Molecular psychiatry · 2019Review
- Review
- Adult Attention-Deficit/Hyperactivity Disorder (ADHD) and Insomnia: an Update of the Literature.Current psychiatry reports · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity associated with clinically significant impairment in functioning. ADHD has an early onset, but frequently persists, with a prevalence estimate of 4% in adults. Dasotraline is a novel compound that is a potent inhibitor of dopamine and norepinephrine transporters that achieves stable plasma concentrations with once-daily dosing. In this study, adult outpatients meeting DSM-IV-TR criteria for ADHD were randomized to 4 weeks of double-blind, once-daily treatment with dasotraline 4 and 8 mg/day or placebo. The primary efficacy end point was change from baseline at week 4 in the ADHD Rating Scale, Version IV (ADHD RS-IV) total score. Secondary efficacy end points included the Clinical Global Impression, Severity (CGI-S) scale, modified for ADHD symptoms. Least squares (LS) mean improvements at week 4 in ADHD RS-IV total score were significantly greater for dasotraline 8 mg/day vs placebo (-13.9 vs -9.7; P=0.019), and nonsignificantly greater for 4 mg/day (-12.4; P=0.076). The LS mean improvements in modified CGI-S were significantly greater at week 4 for dasotraline 8 mg/day vs placebo (-1.1 vs -0.7; P=0.013), and for 4 mg/day vs placebo (-1.1 vs -0.7; P=0.021). The most frequent adverse events reported were insomnia, decreased appetite, nausea, and dry mouth. Discontinuations due to treatment-emergent adverse events were 10.3% and 27.8% of patients in 4 and 8 mg/day treatment groups, respectively. This study provides preliminary evidence that once-daily dosing with dasotraline, a long-acting, dual monoamine reuptake inhibitor, may be a safe and efficacious treatment for adult ADHD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.