A feasibility study evaluating lisdexamfetamine dimesylate for the treatment of adults with bulimia nervosa.

OBJECTIVE: This study examined the feasibility, safety, and potential efficacy of lisdexamfetamine (LDX) as a treatment for adults with bulimia nervosa (BN). METHOD: An open-label 8-week feasibility study was conducted in participants with BN. Enrollment rate, dropout rate, safety outcomes, and eating disorder symptom change were examined. RESULTS: Eighteen of 23 participants completed the study per protocol. There was no participant-initiated dropout due to adverse drug reactions and no severe and unexpected adverse drug reactions. An average increase in heart rate of 12.1 beats/min was observed. There was a mean weight reduction of 2.1 kg and one participant was withdrawn for clinically significant weight loss. In the intent-to-treat sample, there were reductions in objective binge episodes and compensatory behaviors from Baseline to Post/End-of-Treatment (mean difference = -29.83, 95% confidence interval: -43.38 to -16.27; and mean difference = -33.78, 95% confidence interval: -48.74 to -18.82, respectively). DISCUSSION: Results of this study indicate that a randomized controlled trial would be feasible with close monitoring of certain safety parameters (especially over a longer time period as long-term safety is unknown). However, the results should not be used as evidence for clinicians to prescribe LDX to individuals with BN before its efficacy and safety are properly tested. TRIAL REGISTRATION NUMBER: NCT03397446.

Secondary outcomes and qualitative findings of an open-label feasibility trial of lisdexamfetamine dimesylate for adults with bulimia nervosa.

BACKGROUND: There is emerging evidence that stimulants warrant further investigation as a treatment for bulimia nervosa (BN) including a recent open-label feasibility trial examining the use of lisdexamfetamine dimestylate (LDX) for BN. The current report presents the secondary outcomes and qualitative interview results from that feasibility trial. These outcomes explore several purported mechanisms that may explain how stimulants affect symptoms of BN: appetite, impulsivity, obsessive and compulsive symptoms, eating disorder psychopathology/impairment and reward-based decision-making. METHODS: Twenty-three participants with BN received LDX for eight weeks. Questionnaires assessing appetite, impulsivity, obsessive and compulsive symptoms, eating disorder psychopathology and impairment were administered at baseline and post-treatment. Participants also completed a two-step reinforcement learning task to assess their decision-making. Semi-structured interviews took place at baseline, week 5, and follow-up. RESULTS: Reductions in hunger, food-related impulsivity, obsessive and compulsive features, eating disorder psychopathology and impairment were found. However, reward learning, as far as it is assessed by the task, did not seem to contribute to the effect of LDX on BN symptoms. Qualitative analysis suggested four themes: (1) reprieve from the eating disorder, (2) improvement in function and quality of life, (3) renewed hope for recovery, and (4) ability to normalize eating. CONCLUSIONS: This report suggests several potential mechanisms by which LDX may reduce symptoms of binging and purging in those with BN. Importantly, due to the open-label design, we are unable to attribute findings to the medication. Instead, our results should be interpreted as hypothesis generating to inform future studies such as adequately powered randomized controlled trials. Trial registration NCT03397446.

Recent research suggests that stimulant medications could be a potential treatment for bulimia nervosa (BN). Participants in this study took lisdexamfetamine dimesylate (LDX) for 8 weeks while their eating disorder symptoms and medical status were carefully monitored. As part of this study, twenty-three participants with BN completed several interviews, questionnaires and computer tasks at the start and end of treatment which were delivered to help researchers learn more about the how LDX impacts people with BN. Scores on questionnaires measuring different aspects of the eating disorder improved over time. Participants' performance on the computer task which measures a type of decision making did not change during treatment. Interviews exploring participants' experience taking LDX found four common themes: reprieve from the eating disorder, improvement in function and quality of life, renewed hope for recovery, and ability to normalize eating. This report suggests several potential ways LDX may reduce symptoms of binging and purging in those with BN. Importantly, due to the size and type of study, we cannot conclude that changes observed were a direct result of the medication. Instead, our results should be used to form new questions that can be explored by larger studies with controlled designs.

Effect of stimulant medication on loss of control eating in youth with attention deficit/hyperactivity disorder: a prospective, observational case series study protocol.

BACKGROUND: Loss of control eating (LOC-E) in youth predicts the later development of full-syndrome binge-eating disorder (BED), and therefore, could be a relevant target for prevention treatments. To develop these treatments, it is important to understand the underlying disease processes and mechanisms. Based on the putative role of neurocognitive impairments in the pathogenesis of LOC-E, treatments that modulate these neurocognitive factors warrant further exploration. For instance, stimulants are an effective treatment for impulsivity in youth with attention deficit/hyperactivity disorder (ADHD) and have been shown to improve symptoms of BED in adults. Notably, stimulants have not been examined as a treatment for LOC-E in youth. To explore this gap, we aim to measure change in LOC-E episodes and secondary outcomes in youth with comorbid ADHD and LOC-E who are being started on stimulants. METHODS: We will collect prospective observational data on forty 8-to-13-year-old youth diagnosed with comorbid ADHD and LOC-E who are initiating a stimulant for ADHD. Prior to stimulant initiation, participants will complete baseline measures including LOC-E episode frequency in the last 3 months (primary outcome), and secondary outcomes including disordered eating cognitions, emotions and behaviors, ADHD symptom severity, parental LOC-E, impulsivity and reward sensitivity, and anxiety/mood severity. Outcome measurements will be gathered again at 3-months after initiating the stimulant. Within-patient standardized effect sizes with 95% confidence intervals will be calculated from baseline to 3-month follow-up for all outcomes. DISCUSSION: Many individuals with LOC-E or binge eating do not fully remit over the course of psychotherapy. Whereas psychotherapy may address psychological and sociocultural domains associated with LOC-E, some individuals with neurocognitive impairments (e.g., ADHD) and neurobiological deficits (e.g., low intrasynaptic dopamine or norepinephrine) may benefit from adjunctive treatment that targets those factors. This will be the first study to provide pilot data for future studies that could examine both the effect of stimulants on LOC-E in youth and underlying mechanisms. TRIAL REGISTRATION: Trial registration number: NCT05592119.