Binge Eating Disorder Associated With ObesityPhase 3NCT00221442
Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity
A Phase 3 study testing Zonegran and sugar pill in people with Binge Eating Disorder Associated With Obesity, run by Lindner Center of HOPE at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Binge Eating Disorder Associated With Obesity
- What is being tested?
- Zonegran and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0559
About this study
Official title: Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity: A Single Center, Double-Blind, Placebo-controlled, Flexible-Dose Study in Outpatients
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.
Read the detailed description
Binge eating disorder (BED) is characterized by recurrent, uncontrollable, and distressing episodes of excessive food consumption (binge eating) without compensatory weight loss behaviors.1,2 Its prevalence in the general population of the United States is conservatively estimated to be 1.5% to 2%,1-6 making it more common than anorexia nervosa and bulimia nervosa combined. BED is associated with being overweight and obesity.1-7 Approximately 8% to 30% of those seeking standard weight loss treatments, 1-4 up to 50% of those seeking bariatric surgery,8,9 and 70% of those participating in Overeaters Annonymous3 are estimated to have BED.
Zonisamide is a structurally and pharmacologically novel antiepileptic drug - a sulfamate-substituted monosaccharide - with proven anticonvulsant efficacy when used adjunctively in refractory partial epilepsy.10-12 Mechanisms hypothesized to account for zonisamide's antiepileptic properties include antagonism of voltage-gated sodium and T-type calcium channels, blockade of potassium-evoked glutamate release, modulation of central dopaminergic and serotonergic function, and carbonic anhydrase inhibition.10-16 Several lines of evidence suggest that zonisamide might be a useful treatment for BED. First, like the anticonvulsant topiramate,17-19 zonisamide has been associated with anorexia and weight loss in clinical trials in epilepsy patients10,11,20 and in patients with obesity.20 Topiramate has also been shown to reduce binge eating and weight in patients with binge eating disorder associated with obesity. 21 Although zonisamide and topiramate have distinct pharmacologic profiles, both drugs share several pharmacologic actions. These include sodium channel blockade, carbonic anhydrase inhibition, and reduction of glutamate neurotransmission. 10,11,13,16,17 Regarding the latter property, animal studies have shown that stimulation of the lateral hypothalamus by glutamate and glutamate agonists causes an intense, rapid, dose-dependent increase in food intake,22 whereas glutamate antagonism of the nucleus tractus solitarius reduces food intake.23 Second, unlike topiramate, zonisamide also modulates the function of serotonin and dopamine14, 15 --two neurotransmitters involved in the regulation of feeding behavior24 and the mechanisms of some medications with efficacy in either binge eating (SSRIs, d-fenfluramine) 25-29 or obesity (sibutramine, stimulants).30 Third, a broad range of antidepressants have been reported to reduce binge eating in both bulimia nervosa31 and binge eating disorder25-28,32 and preliminary observations suggest zonisamide may have thymoleptic properties.33,34 Fourth, in an open-label trial of zonisamide in 15 patients with BED conducted by our group, zonisamide was effective in reducing binge eating frequency, severity of illness, and weight (S.L. McElroy, J Clin Psychiatry, under review).35 We therefore propose to conduct a double-blind, placebo-controlled, randomized, parallel group, 16-week study of zonisamide in 60 outpatients with binge eating disorder and obesity.
- Being tested
- Zonegran, sugar pill
- Keywords
- Adults, Binge eating disorder, Blood draw, E.Coli enterprotoxin, Eating disorders, Electrocardiogram, Females, Males, Physical exam, Psychiatric evaluation, Questionnaire
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonegranDrug
zonegran (zonisamide)
sugar pillDrug
fake pill
| Study group | Role | What they receive |
|---|---|---|
| zonisamide | Active comparator | zonegran (zonisamide) Receives: Drug: Zonegran |
| Sugar pill | Placebo comparator | fake pill Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of binge eating episodes
Measured: per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating Disorder Associated With ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc., University of Cincinnati
- Investigators
- Susan L McElroy, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221442
- Sponsor's protocol ID
- 51-345-740
- Status last verified
- Jun 2011
- First submitted
- 14 Sep 2005
- Last updated
- 22 Jun 2011
- Results posted
- No
Publications
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.
PubMed 17194267
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity: A Single Center, Double-Blind, Placebo-controlled, Flexible-Dose Study in Outpatients
- ClinicalTrials.gov ID
- NCT00221442
- Acronym / sponsor ID
- 51-345-740
- Keywords
- Adults, Binge eating disorder, Blood draw, E.Coli enterprotoxin, Eating disorders, Electrocardiogram, Females, Males
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Eisai Inc., University of Cincinnati
- Study start
- Aug 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Binge eating disorder (BED) is characterized by recurrent, uncontrollable, and distressing episodes of excessive food consumption (binge eating) without compensatory weight loss behaviors.1,2 Its prevalence in the general population of the United States is conservatively estimated to be 1.5% to 2%,1-6 making it more common than anorexia nervosa and bulimia nervosa combined. BED is associated with being overweight and obesity.1-7 Approximately 8% to 30% of those seeking standard weight loss treatments, 1-4 up to 50% of those seeking bariatric surgery,8,9 and 70% of those participating in Overeaters Annonymous3 are estimated to have BED.
Zonisamide is a structurally and pharmacologically novel antiepileptic drug - a sulfamate-substituted monosaccharide - with proven anticonvulsant efficacy when used adjunctively in refractory partial epilepsy.10-12 Mechanisms hypothesized to account for zonisamide's antiepileptic properties include antagonism of voltage-gated sodium and T-type calcium channels, blockade of potassium-evoked glutamate release, modulation of central dopaminergic and serotonergic function, and carbonic anhydrase inhibition.10-16 Several lines of evidence suggest that zonisamide might be a useful treatment for BED. First, like the anticonvulsant topiramate,17-19 zonisamide has been associated with anorexia and weight loss in clinical trials in epilepsy patients10,11,20 and in patients with obesity.20 Topiramate has also been shown to reduce binge eating and weight in patients with binge eating disorder associated with obesity. 21 Although zonisamide and topiramate have distinct pharmacologic profiles, both drugs share several pharmacologic actions. These include sodium channel blockade, carbonic anhydrase inhibition, and reduction of glutamate neurotransmission. 10,11,13,16,17 Regarding the latter property, animal studies have shown that stimulation of the lateral hypothalamus by glutamate and glutamate agonists causes an intense, rapid, dose-dependent increase in food intake,22 whereas glutamate antagonism of the nucleus tractus solitarius reduces food intake.23 Second, unlike topiramate, zonisamide also modulates the function of serotonin and dopamine14, 15 --two neurotransmitters involved in the regulation of feeding behavior24 and the mechanisms of some medications with efficacy in either binge eating (SSRIs, d-fenfluramine) 25-29 or obesity (sibutramine, stimulants).30 Third, a broad range of antidepressants have been reported to reduce binge eating in both bulimia nervosa31 and binge eating disorder25-28,32 and preliminary observations suggest zonisamide may have thymoleptic properties.33,34 Fourth, in an open-label trial of zonisamide in 15 patients with BED conducted by our group, zonisamide was effective in reducing binge eating frequency, severity of illness, and weight (S.L. McElroy, J Clin Psychiatry, under review).35 We therefore propose to conduct a double-blind, placebo-controlled, randomized, parallel group, 16-week study of zonisamide in 60 outpatients with binge eating disorder and obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zonisamide | Active comparator | Drug: Zonegranzonegran (zonisamide) |
| Sugar pill | Placebo comparator | Drug: sugar pillfake pill |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Marked distress regarding binge eating.
- The binge eating occurs, on average, at least two days a week for six months.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonegranzonegran (zonisamide) | Drug | zonisamide |
| sugar pillfake pill | Drug | Sugar pill |
Primary outcome
frequency of binge eating episodes
Time frame: per protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Results publication: PubMed 17194267McElroy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L McElroy, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zonegran and sugar pill in people with Binge Eating Disorder Associated With Obesity, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of binge eating episodes (time frame: per protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011.