Double-Blind, Randomized, Placebo-Controlled Trial of Topiramate Plus Cognitive-Behavior Therapy in Binge-Eating Disorder

Department of Psychiatry, Universidade Federal de São Paulo, Brazil.
The Journal of Clinical Psychiatry (Impact Factor: 5.5). 09/2007; 68(9):1324-32. DOI: 10.4088/JCP.v68n0901
Source: PubMed


To evaluate the efficacy and tolerability of adjunctive topiramate compared to placebo in reducing weight and binge eating in obese patients with binge-eating disorder (BED) receiving cognitive-behavior therapy (CBT).
A double-blind, randomized, placebo-controlled trial of 21 weeks' duration was conducted at 4 university centers. Participants were 73 obese (body mass index >or= 30 kg/m(2)) outpatients with BED (DSM-IV criteria), both genders, and aged from 18 to 60 years. After a 2- to 5-week run-in period, selected participants were treated with group CBT (19 sessions) and topiramate (target daily dose, 200 mg) or placebo (September 2003-April 2005). The main outcome measure was weight change, and secondary outcome measures were binge frequencies, binge remission, Binge Eating Scale (BES) scores, and Beck Depression Inventory (BDI) scores.
Repeated-measures random regression analysis revealed a greater rate of weight reduction associated with topiramate over the course of treatment (p < .001), with patients taking topiramate attaining a clinically significant weight loss (-6.8 kg) compared to patients taking placebo (-0.9 kg). Although rates of reduction of binge frequencies, BES scores, and BDI scores did not differ between groups during treatment, a greater number of patients of the topiramate plus CBT group (31/37) attained binge remission compared to patients taking placebo (22/36) during the trial (p = .03). No difference between groups was found in completion rates; 1 patient (topiramate group) withdrew for adverse effect. Paresthesia and taste perversion were more frequent with topiramate, and insomnia was more frequent with placebo (p < .05).
Topiramate added to CBT improved the efficacy of the later, increasing binge remission and weight loss in the short run. Topiramate was well tolerated, as shown by few adverse events during treatment. identifier NCT00307619.

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    • "h in the obesity field ( Wadden et al . , 2005 ) . Our finding that sibutramine enhanced shCBT weight loss outcomes is consistent with two previous studies reporting sig - nificant " additive " effects by combining certain specific medica - tions with weight - loss effects ( e . g . , orlistat , topiramate ) and " guided " CBT treatments for BED ( Claudino et al . , 2007 ; Grilo , Masheb , & Salant , 2005 ) . Comparisons with the existing treatment literature , as offered descriptively for context above , can only be made cautiously given potentially important differences between generalist and specialist treatment settings and providers . For example , we note striking differences in findings from two "
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    ABSTRACT: Objective The objective was to determine whether treatments with demonstrated efficacy for binge eating disorder (BED) in specialist treatment centers can be delivered effectively in primary care settings to racially/ethnically diverse obese patients with BED. This study compared the effectiveness of self-help cognitive-behavioral therapy (shCBT) and an anti-obesity medication (sibutramine), alone and in combination, and it is only the second placebo-controlled trial of any medication for BED to evaluate longer-term effects after treatment discontinuation. Method 104 obese patients with BED (73% female, 55% non-white) were randomly assigned to one of four 16-week treatments (balanced 2-by-2 factorial design): sibutramine (N=26), placebo (N=27), shCBT+sibutramine (N=26), or shCBT+placebo (N=25). Medications were administered in double-blind fashion. Independent assessments were performed monthly throughout treatment, post-treatment, and at 6- and 12-month follow-ups (16 months after randomization). Results Mixed-models analyses revealed significant time and medication-by-time interaction effects for percent weight loss, with sibutramine but not placebo associated with significant change over time. Percent weight loss differed significantly between sibutramine and placebo by the third month of treatment and at post-treatment. After the medication was discontinued at post-treatment, weight re-gain occurred in sibutramine groups and percent weight loss no longer differed among the four treatments at 6- and 12-month follow-ups. For binge-eating, mixed-models revealed significant time and shCBT-by-time interaction effects: shCBT had significantly lower binge-eating frequency at 6-month follow-up but the treatments did not differ significantly at any other time point. Demographic factors did not significantly predict or moderate clinical outcomes. Discussion Our findings suggest that pure self-help CBT and sibutramine did not show long-term effectiveness relative to placebo for treating BED in racially/ethnically diverse obese patients in primary care. Overall, the treatments differed little with respect to binge-eating and associated outcomes. Sibutramine was associated with significantly greater acute weight loss than placebo and the observed weight-regain following discontinuation of medication suggests that anti-obesity medications need to be continued for weight loss maintenance. Demographic factors did not predict/moderate clinical outcomes in this diverse patient group.
    Behaviour Research and Therapy 07/2014; 58. DOI:10.1016/j.brat.2014.04.002 · 3.85 Impact Factor
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    • "Topiramate is an antiepileptic drug found to be useful for alcohol dependence, weight-loss, and BED (Claudino et al., 2007; McElroy et al., 2003, 2007) and has been examined in three randomized, placebo-controlled trials. Two of the three trials found that compared to the placebo-group, those receiving topiramate had significant reductions in binging frequency (Claudino et al., 2007; McElroy et al., 2007). "
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    ABSTRACT: Background and aims: Binge eating disorder (BED) is a relatively common condition, especially in young adult females, and is characterized by chronic over-consumption of food resulting in embarrassment, distress, and potential health problems. It is formally included as a disorder in DSM-5 for the first time, an acknowledgement to its debilitating nature. This article explores the overlap between binge eating disorder and substance use disorders (SUD). Methods: The bibliographic search was a computerized screen of PubMed databases from January 1990 to the present. Binge eating disorder, substance use disorder, binging, obesity, food addiction, comorbidity, dopamine, opioid, serotonin, glutamate, and pharmacological treatment were the keywords used in searching. Results: BED shares similar phenomenology to SUD, including significant urges to engage in binging episodes, resulting in distress and impairment. Similar neurobiological pathways are found in both BED and SUD and medications based on similar neurobiology have been examined for both disorders. A subset of individuals with BED may have a "food addiction", but there is no clinical agreement on the meaning of "food addiction". Exploring the relationship between BED and obesity may also shed light on the extent to which BED can be viewed as an addiction. Conclusions: Overall, nascent research regarding BED and SUD suggests an overlap between these disorders, but there are discrepancies between these two disorders that need further exploration.
    Journal of Behavioural Addictions 12/2013; 2(4):191-8. DOI:10.1556/JBA.2.2013.015 · 1.87 Impact Factor
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    • "As the Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition (SCID-I/P) was used as a study measure in the original trial, two items were also considered for the inclusion of participants in this study: the first question of the BN module that investigates the presence of binge eating, where only item A2 – LOC – was needed to score positively), and item D of the BED module (also scoring positively either with a threshold or subthreshold score). Thus, the sample considered for this study could include volunteers who did not meet full inclusion criteria for the original trial (see details in Claudino et al.) [28]. For instance, participants could be included if they reported recurrent LOC over eating associated with eating large amounts of food (OBE) or not (SBE) and with frequency/duration meeting DSM-IV criteria (twice a week for six months – criteria for BED) or lower (at least once a week for six months). "
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    ABSTRACT: Background Objective binge eating episodes (OBEs) refer to binge eating on an unusually large amount of food and are the core symptom in current definitions of bulimia nervosa (BN) and binge eating disorder (BED). Subjective binge eating episodes (SBEs) refer to eating on a small or moderate amount of food (that is perceived as large) and like OBEs are associated with loss of control (LOC). Reaching consensus on what is considered a large amount of food can however be problematic and it remains unclear if the size of a binge is an essential component for defining a binge eating episode. The aim of this study was to compare the eating disorder features and general psychopathology of subjects reporting OBEs with those reporting only SBEs. Methods This is a retrospective secondary analysis of data from 70 obese participants at the recruitment phase of a multicentre trial for BED. Individuals who answered positively to the presence of binge eating and LOC over eating had their binge eating episodes further explored by interview and self-report. Two groups, those who reported current OBEs (with or without SBEs) and those who reported current SBEs only were compared for age, gender, marital status, body mass index (BMI), indicators of LOC over eating, severity of binge-eating and associated psychopathology. Results The majority of participants in both the OBE and SBE groups endorsed the experience of at least four indicators of LOC. There were no significant differences between the groups. Both groups had high levels of binge-eating severity, moderate severity of associated depressive symptoms and frequent psychiatric co-morbidity. Conclusion Treatment seeking participants with obesity who reported SBEs alone were similar to those who reported OBEs in terms of eating disorder features and general psychopathology. These findings suggest that classificatory systems of mental illnesses should consider introducing SBEs as a feature of the diagnostic criteria for binge eating and, thus, facilitate the inclusion of participants with SBEs in treatment trials.
    International Journal of Eating Disorders 08/2013; 1(1):26. DOI:10.1186/2050-2974-1-26 · 3.13 Impact Factor
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