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.

The costs and benefits of intensive day treatment programs and outpatient treatments for eating disorders: An idea worth researching.

Outpatient care (e.g., individual, group, or self-help therapies) and day treatment programs (DTPs) are common and effective treatments for adults with eating disorders. Compared to outpatient care, DTPs have additional expenses and could have unintended iatrogenic effects (e.g., may create an overly protective environment that undermines self-efficacy). However, these potential downsides may be offset if DTPs are shown to have advantages over outpatient care. To explore this question, our team conducted a scoping review that aimed to synthesize the existing body of adult eating disorder literature (a) comparing outcomes for DTPs to outpatient care, and (b) examining the use of DTPs as a higher level of care in a stepped care model. Only four studies met the predefined search criteria. The limited results suggest that the treatments have similar effects and that outpatient care is more cost-effective. Furthermore, no studies explored the use of DTPs as a higher level of care in a stepped care model (despite international guidelines recommending this approach). Given the clear dearth of literature on this clinically relevant topic, we have provided specific avenues for further research.

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.

Understanding the effects of reductionist biological views of eating disorder etiology on patient attitudes and behavior.

While eating disorders were historically considered to be a result of psychological or environmental causes, current evidence suggests that eating disorders are the product of complex gene-environment interactions wherein heritable vulnerabilities are activated by multiple exposures to environmental stimuli over the lifespan. Despite the fact that this integrated biopsychosocial etiological view of eating disorders is accepted among many professionals in the eating disorder field, evidence suggests that the general public and some clinicians are susceptible to dualist, or reductionist, views of psychopathology. Currently, little is known about (a) the prevalence of reductionist biological views of eating disorder etiology in those with eating disorders (this view attributes the cause of eating disorders to predominantly biological factors but does not acknowledge psychosocial factors as important contributors), (b) the effects of reductionist biological views on clinical outcomes, and (c) the most effective methods for modifying these views. In this article, we present the results of a preliminary investigation on the relationship between perceived causes of eating disorders and the attitudes and behaviors of those with eating disorders. We then go on to propose specific avenues for further research on uncovering the effects of reductionist biological views of eating disorder etiology.

Client relationship incidents in early therapy: doorways to collaborative engagement.

The purpose of this study was to elaborate how clients understand the development of the alliance and to highlight aspects of the process particular to depressed clients working with experienced therapists. Fifteen participants described critical incidents in early therapy that influenced how they understood their working relationships with therapists. All incidents involved clients appraising what their therapists were doing. Through interviewer probing, participants were able to identify the importance of their own activity (disclosing and working with therapist input) as their collaboration in the incidents. Positive emotional responses were woven through the descriptions of the incidents. The research underscores how client understanding of collaboration might be accessed by researchers or clinicians and the potential importance of the interaction of client active exploration with positive emotions in understanding alliance development.