According to the Mayo Clinic, "binge eating disorder" is a condition in which an individual "frequently consume[s] unusually large amounts of food." The US Department of Health and Human Services (HHS) Weight-Control Information Network (WIN) says that as many as 3.5% of American women and 2% of American men may have this eating disorder. An HHS WIN fact sheet says that binge eating disorder has an unknown etiology, with a mix of possible causes: psychological, emotional, social, and genetic.
Unlike bulimia, binge eating disorder does not involve self-induced vomiting or diarrhea; thus it often results in unhealthy weight gain. Doctors at the Mayo Clinic include the attainment and maintenance of a healthy weight as one of the goals of binge eating disorder treatment. They note that individual or group psychotherapy sessions may help to heal binge eating disorder. Specifically, cognitive behavioral therapy (CBT) may help to identify and mitigate the triggers of binge eating episodes; interpersonal psychotherapy may remediate binge eating disorders by improving the patient's ability to form healthy relationships with others; dialectical behavior therapy may help individuals with binge eating disorder to adopt behaviors to combat stressful situations that may provoke binge eating episodes.
Mayo Clinic staff note that no medication is currently approved to treat binge eating disorder, but mention a few types of medications sometimes prescribed off-label for individuals with the condition. Of tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs), the Mayo Clinic states, "It's not clear how these can reduce binge eating." Of topiramate, an anti-seizure drug often marketed as Topamax, the Mayo Clinic says, "topiramate has ... been found to reduce binge-eating episodes," but cautions, "potentially it can cause serious side effects, so discuss these risks with your doctor." Some of these side effects include permanent loss of vision, metabolic acidosis, and suicidal thoughts or actions. Topiramate is also teratogenic; it can cause birth defects in the children of women who take it while pregnant.
Despite the limited evidence supporting the use of medication to address binge eating disorder, Shire Development LLC, a pharmaceutical firm, is backing a clinical trial of its drug Lisdexamfetamine dimesylate (commonly known as the ADHD drug Vyvanse) for the treatment of binge eating disorder. The study, identified in the national clinical trial registry as NCT01657019, has 84 locations, including the Lehigh Center for Clinical Research in Allentown.
Lisexamfetamine dimesylate is known as a "prodrug," because it must be broken down by the body: split into the lysine component of the molecule and the active drug, dextroamphetamine. The trial currently recruiting patients is a phase III trial, which is generally used to confirm the safety and efficacy of a drug. The outcome measures of this trial are: the occurrence of treatment-emergent adverse effects (TEAEs) as a measure of safety (primary outcome), patients' scores on the Columbia Suicide Severity Rating Scale (C-SSRS) as a measure of safety (primary outcome), patients' scores on the Clinical Global Impressions of Improvement (CGI-I) scale (secondary outcome), patients' responses to the Eating Disorder Examination Questionnaire (EDE-Q) (secondary outcome), and patients' responses to the EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) (secondary outcome).
Rigorous safety testing seems prudent, given the known side effects of Lisdexamfetamine dimesylate as administered for the treatment of ADHD. Reported side effects include sudden death, stroke, and heart attack in adults; the Vyvanse medication guide warns parents of children treated with Vyvanse to be on the lookout for "new psychotic symptoms such as hearing voices" and "seeing or hearing things that are not real." Additionally, researchers have found that prescription amphetamines "can produce marked psychological adverse events, including stimulant-induced psychosis." An article published in a 2009 issue of Molecular Psychiatry advises, "Assessments of central toxicity and adverse psychological effects ... of adults who receive prolonged courses of amphetamine treatment are warranted." In its most recent safety update concerning this class of drug, the FDA recommended that lisdexamfetamine dimesylate "generally not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic." The research and health communities will likely scrutinize the outcome of this study in order to determine what support, if any, it offers for the use of amphetamines in treating binge eating disorder.