Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2011
Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials.
Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses 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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison.European child & adolescent psychiatry · 2017Pooled it
- Stimulant treatment of ADHD and cigarette smoking: a meta-analysis.Pediatrics · 2014Pooled it
- A randomized, double-blind, placebo-controlled crossover study of α4β 2* nicotinic acetylcholine receptor agonist AZD1446 (TC-6683) in adults with attention-deficit/hyperactivity disorder.Psychopharmacology · 2014Trial
- A randomized, double-blind, placebo-controlled phase 2 study of α4β2 agonist ABT-894 in adults with ADHD.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2013Trial
- Efficacy and safety of the novel α₄β₂ neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study.Psychopharmacology · 2012Trial
- Prospects for new drugs to treat binge-eating disorder: Insights from psychopathology and neuropharmacology.Journal of psychopharmacology (Oxford, England) · 2022Review
- New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development.Current topics in behavioral neurosciences · 2022Review
- Therapeutic Applications of Nicotinic Stimulation: Successes, Failures, and Future Prospects.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019Article
- The contribution of agonist and antagonist activities of α4β2* nAChR ligands to smoking cessation efficacy: a quantitative analysis of literature data.Psychopharmacology · 2018Review
- Nicotinic α4β2 Cholinergic Receptor Influences on Dorsolateral Prefrontal Cortical Neuronal Firing during a Working Memory Task.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2017Article
- Targeting the nicotinic cholinergic system to treat attention-deficit/hyperactivity disorder: rationale and progress to date.CNS drugs · 2014Review
- Nicotinic acetylcholine receptors in attention circuitry: the role of layer VI neurons of prefrontal cortex.Cellular and molecular life sciences : CMLS · 2014Review
- Unravelling the mechanism of action of NS9283, a positive allosteric modulator of (α4)3(β2)2 nicotinic ACh receptors.British journal of pharmacology · 2013Article
- Leveraging the cortical cholinergic system to enhance attention.Neuropharmacology · 2013Review
- Chemistry and behavioral studies identify chiral cyclopropanes as selective α4β2-nicotinic acetylcholine receptor partial agonists exhibiting an antidepressant profile.Journal of medicinal chemistry · 2012Article
- Efficacy and safety of atomoxetine in the treatment of children and adolescents with attention deficit hyperactivity disorder.Clinical medicine insights. Pediatrics · 2012Article
- Deficits in attentional control: cholinergic mechanisms and circuitry-based treatment approaches.Behavioral neuroscience · 2011Review
- Neurobiology of nAChRs and cognition: a mini review of Dr. Jerry J. Buccafusco's contributions over a 25 year career.Biochemical pharmacology · 2011Review
- An update on the pharmacotherapy of attention-deficit/hyperactivity disorder in adults.Expert review of neurotherapeutics · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 2 countries.
Funding
Abstract
objectiveTo assess the safety and efficacy of ABT-089, a novel α(4)β(2) neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD).
methodTwo multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years of age were conducted. Study 1 (n = 274) assessed six treatment groups over 8 weeks: 4 once-daily (QD) ABT-089 doses (0.085-0.700 mg/kg), QD atomoxetine, and placebo. Study 2 (n = 119) assessed three treatment groups over 6 weeks: 2 QD ABT-089 doses (0.7 mg/kg, 1.4 mg/kg) and placebo. The primary efficacy variable was the investigator-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV: Home Version (ADHD-RS-IV [HV]) Total Score. Safety was assessed by adverse event (AE) monitoring, laboratory tests, vital signs, physical examinations, and electrocardiogram measures.
resultsThere was no statistically significant difference between ABT-089 and placebo in mean change from baseline to final evaluation of ADHD-RS-IV (HV) Total Score or other outcome measures at any dose in either study. In Study 1, atomoxetine showed statistically significant improvement for the primary and most secondary endpoints. ABT-089 was generally safe and well tolerated, with no statistically significant difference between any ABT-089 dose and placebo in the overall incidence of any specific AE, and no clinically significant changes in other safety measures.
conclusionsABT-089 did not show efficacy on the primary efficacy variable, the ADHD-RS-IV (HV) Total Score, or other measures of ADHD symptomatology in children with ADHD, and had a safety profile similar to placebo. These results contrast with published reports of efficacy of nicotinic modulators in adults with ADHD.
Indexed as
Identifiers
What OpenQuestion holds
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.