Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity

NCT00221442 | Completed Phase 3

• 1 other identifier: 51-345-740
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this study is to examine the efficacy and safety of zonisamide compared with placebo in outpatients with binge eating disorder associated with obesity.

Conditions

Binge Eating Disorder Associated With Obesity

Keywords

Adults; Binge eating disorder; Blood draw; E.Coli enterprotoxin; Eating disorders; Electrocardiogram; Females; Males; Physical exam; Psychiatric evaluation; Questionnaire

Outcome Measures

Primary Outcomes (1)

• frequency of binge eating episodes

  per protocol

Study Arms (2)

zonisamide

ACTIVE COMPARATOR

zonegran (zonisamide)

Drug: Zonegran

Sugar pill

PLACEBO COMPARATOR

fake pill

Drug: sugar pill

Interventions

Zonegran DRUG

zonegran (zonisamide)

zonisamide

sugar pill DRUG

fake pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will meet DSM-IV criteria for BED for at least the last 6 months. These criteria are as follows:
• Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: (1) eating, in discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances and (2) a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating)
• The binge eating episodes are associated with at least three of the following:
• Eating much more rapidly than normal
• Eating until uncomfortably full
• Eating large amounts of food when not feeling physically hungry
• Eating alone because of being embarrassed by how much one is eating
• Feeling disgusted with oneself, depressed, or feeling very guilty after overeating
• Marked distress regarding binge eating.
• The binge eating occurs, on average, at least two days a week for six months.
• Does not occur exclusively during the course of bulimia nervosa and anorexia nervosa.
• Obesity as defined by body mass index \> 30 kg/m2.
• Men or women, between the ages of 18 and 65. The patient population is expected to be predominantly made up of women based on previous research.

You may not qualify if:

• Have current body mass index \< 30kg/m2.
• Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
• Subjects who are displaying clinically significant suicidality or homicidality.
• Subjects who are displaying a current clinically unstable depressive disorder (e.g., HAM-D \> 21).
• A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence.
• A lifetime history of a DSM-IV bipolar disorder or dementia.
• History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures.
• Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study.
• History of seizures, including febrile seizures in childhood
• History of clinically significant nephrolithiasis.
• Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g. stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs).
• Subjects who have received psychoactive medication (other than zaleplon \[Sonata\] or zolpidem \[Ambien\] -- as needed for restlessness/insomnia) within one week prior to randomization.
• Subjects who have begun and/or are receiving formal psychotherapy (cognitive behavioral therapy, interpersonal therapy, or dietary behavioral therapy) for BED or weight loss within the past 3 months.
• Subjects previously enrolled in this study or have previously been treated with zonisamide.
• Subjects who have received an experimental drug or used an experimental device within 30 days.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Eisai Inc.: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related Publications (1)

• McElroy SL, Kotwal R, Guerdjikova AI, Welge JA, Nelson EB, Lake KA, D'Alessio DA, Keck PE, Hudson JI. Zonisamide in the treatment of binge eating disorder with obesity: a randomized controlled trial. J Clin Psychiatry. 2006 Dec;67(12):1897-906. doi: 10.4088/jcp.v67n1209.

  PMID: 17194267 RESULT

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders

Interventions

Zonisamide; Sugars

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Susan L McElroy, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

US (1)