Trial reportJournal of clinical psychopharmacology2017
A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder.
Trial report in Journal of clinical psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01657019 (A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Phase 3, Multicenter, Open-label, 12 Month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults With Binge Eating Disorder
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effect of amphetamines on blood pressure.The Cochrane database of systematic reviews · 2025Pooled it
- The effects of lisdexamfetamine dimesylate on eating behaviour and homeostatic, reward and cognitive processes in women with binge-eating symptoms: an experimental medicine study.Translational psychiatry · 2022Trial
- Patient perceptions of lisdexamfetamine as a treatment for binge eating disorder: An exploratory qualitative and quantitative analysis.Psychiatry research communications · 2024Article
- Exploring bi-directional impacts of Lisdexamfetamine dimesylate on psychological comorbidities and quality of life in people with Binge Eating Disorder.Journal of eating disorders · 2024Article
- Pharmacotherapy, alternative and adjunctive therapies for eating disorders: findings from a rapid review.Journal of eating disorders · 2023Review
- Review
- Review
- Binge eating disorder.Nature reviews. Disease primers · 2022Article
- Converging vulnerability factors for compulsive food and drug use.Neuropharmacology · 2021Review
- Binge Eating Disorder: A 5-Year Retrospective Study on Experimental Drugs.Journal of experimental pharmacology · 2021Review
- Binge-Like Eating Is Not Influenced by the Murine Model ofFrontiers in psychology · 2019Article
- Understanding the neural mechanisms of lisdexamfetamine dimesylate (LDX) pharmacotherapy in Binge Eating Disorder (BED): a study protocol.Journal of eating disorders · 2019Article
- A 12-Month Open-Label Extension Study of the Safety and Tolerability of Lisdexamfetamine Dimesylate for Major Depressive Disorder in Adults.Journal of clinical psychopharmacology · 2018Article
- Safety of pharmacotherapy options for bulimia nervosa and binge eating disorder.Expert opinion on drug safety · 2018Review
- Lisdexamfetamine: A Review in Binge Eating Disorder.CNS drugs · 2017Review
- Pharmacotherapy of eating disorders.Current opinion in psychiatry · 2017Review
- Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study.Advances in therapy · 2017Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED).
methodsAdults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50- or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses.
resultsOf the 604 enrolled participants, 599 (521 women and 78 men) comprised the safety analysis set, and 369 completed the study. Mean (SD) LDX exposure was 284.3 (118.84) days; cumulative LDX exposure duration was 12 months or longer in 344 participants (57.4%). A total of 506 participants (84.5%) reported TEAEs (TEAEs leading to treatment discontinuation, 54 [9.0%]; severe TEAEs, 42 [7.0%]; serious TEAEs, 17 [2.8%]). Treatment-emergent adverse events reported in greater than or equal to 10% of participants were dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infection (11.4%). Mean (SD) changes from antecedent study baseline in systolic and diastolic blood pressure, pulse, and weight at week 52/early termination (n = 597) were 2.19 (11.043) and 1.77 (7.848) mm Hg, 6.58 (10.572) beats per minute, and -7.04 (7.534) kg, respectively. On the Columbia-Suicide Severity Rating Scale, there were 2 positive responses for any active suicidal ideations; there were no positive responses for suicidal behavior or completed suicides.
conclusionsIn this 12-month, open-label, extension study, the long-term safety and tolerability of LDX in adults with BED were generally consistent with its established profile for attention-deficit/hyperactivity disorder.
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