Trial reportCNS spectrums2021
Efficacy and safety of dasotraline in adults with binge-eating disorder: a randomized, placebo-controlled, fixed-dose clinical trial.
Trial report in CNS spectrums, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System.Clinical drug investigation · 2026Pooled it
- The Role of the Noradrenergic System in Eating Disorders: A Systematic Review.International journal of molecular sciences · 2021Pooled it
- Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up.Obesity (Silver Spring, Md.) · 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
- The Relationship Between Binge Eating Behavior and Psychological Pain in Patients with Major Depressive Disorder.Behavioral sciences (Basel, Switzerland) · 2025Article
- Pharmacotherapy, alternative and adjunctive therapies for eating disorders: findings from a rapid review.Journal of eating disorders · 2023Review
- SipNose-topiramate: a potential novel approach to binge eating management.Journal of eating disorders · 2023Article
- Management of eating disorders for people with higher weight: clinical practice guideline.Journal of eating disorders · 2022Article
- 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
- Binge eating disorder.Nature reviews. Disease primers · 2022Article
- A literature review of dopamine in binge eating.Journal of eating disorders · 2022Review
- The Neurobiology of Binge-eating Disorder Compared with Obesity: Implications for Differential Therapeutics.Clinical therapeutics · 2021Review
- Binge Eating Disorder: A 5-Year Retrospective Study on Experimental Drugs.Journal of experimental pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveThe aim of this fixed-dose study was to evaluate the efficacy and safety of dasotraline in the treatment of patients with binge-eating disorder (BED).
methodsPatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for BED were randomized to 12 weeks of double-blind treatment with fixed doses of dasotraline (4 and 6 mg/d), or placebo. The primary efficacy endpoint was change in number of binge-eating (BE) days per week at week 12. Secondary efficacy endpoints included week 12 change on the BE CGI-Severity Scale (BE-CGI-S) and the Yale-Brown Obsessive-Compulsive Scale Modified for BE (YBOCS-BE).
resultsAt week 12, treatment with dasotraline was associated with significant improvement in number of BE days per week on the dose of 6 mg/d (N = 162) vs placebo (N = 162; -3.47 vs -2.92; P = .0045), but not 4 mg/d (N = 161; -3.21). Improvement vs placebo was observed for dasotraline 6 and 4 mg/d, respectively, on the BE-CGI-S (effect size [ES]: 0.37 and 0.27) and on the YBOCS-BE total score (ES: 0.43 and 0.29). The most common adverse events on dasotraline were insomnia, dry mouth, headache, decreased appetite, nausea, and anxiety. Changes in blood pressure and pulse were minimal.
conclusionTreatment with dasotraline 6 mg/d (but not 4 mg/d) was associated with significantly greater reduction in BE days per week. Both doses of dasotraline were generally safe and well-tolerated and resulted in global improvement on the BE-CGI-S, as well as improvement in BE related obsessional thoughts and compulsive behaviors on the YBOCS-BE. These results confirm the findings of a previous flexible dose study.
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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.