An Innovative Disease-Drug-Trial Framework to Guide Binge Eating Disorder Drug Development: A Case Study for Topiramate.

About this resource

As with other psychiatric disorders, development of drugs to treat binge-eating disorder (BED) has been hampered by high placebo response and dropout rates in randomized controlled trials (RCTs). Although not approved for use in BED, several RCTs have suggested that topiramate is efficacious for BED in obese individuals. Using data from a positive investigator-initiated RCT of topiramate in 61 obese individuals with BED, the objective of the present study is (i) to develop a quantitative disease-drug-trial framework to inform future BED clinical trial designs, and (ii) to determine the optimal topiramate dose to achieve therapeutic efficacy. Disease-drug-trial models were developed separately for the two efficacy measures, namely, longitudinal normalized weekly binge-eating episode frequency (BEF) and binge day frequency (BDF). Model building consisted of (i) developing a placebo effect model that describes response from the placebo group, (ii) adding a drug effect to the placebo model to describe dose-response relationships, and (iii) developing a parametric time to event model to characterize patient dropout patterns. The placebo effect on normalized BEF and BDF over time demonstrated a maximum decrease of ~ 57% by 5 weeks. Participants had a higher dropout probability if no weight loss occurred during the trial period. The identified dose-response relationship demonstrated a daily dose of 125 mg was needed to exhibit a marked reduction in weekly BEF. The developed comprehensive disease-drug-trial model will be utilized to simulate different clinical trial designs to increase the success for future BED drug development programs.

AuthorKalaria, Shamir N.; McElroy, Susan L.; Gobburu, Jogarao; Gopalakrishnan, Mathangi
JournalClinical and translational science
Volume13
Year2020

See also

Clinical significance and distinctiveness of purging disorder and binge eating disorder

In the DSM-IV, individuals with binge eating disorder (BED) and those with purging disorder (PD) receive a diagnosis of eating disorder not otherwise specified (EDNOS), suggesting no meaningful differences between clinical presentations.

Read more

Associations between ADHD and eating disorders in relation to comorbid psychiatric disorders in a nationally representative sample.

The objective of this study was to examine whether previously observed associations of attention-deficit/hyperactivity disorder (ADHD) with eating disorders (EDs) are at least partially attributable to other underlying psychopathology.

Read more

Lifetime and 12-month prevalence of eating disorders amongst women in mid-life: a population-based study of diagnoses and risk factors

BACKGROUND Eating disorders (EDs) are common amongst women; however, no research has specifically investigated the lifetime/12-month prevalence of eating disorders amongst women in mid-life (i.e., fourth and fifth decade of life) and the relevant longitudinal risk factors.

Read more

Treatment of obese patients with binge eating disorder using topiramate: A review

Topiramate is an anticonvulsant drug used for the treatment of epilepsy and prophylaxis of migraine.

Read more

Help us improve!

Give us feedback!

We will continue throughout 2020 to update and improve the NEDC website and welcome any feedback you may have on the site.

Provide feedback