Binge Eating DisorderPhase 3NCT00277641
Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity
A Phase 3 study testing Lamotrigine in people with Binge Eating Disorder and Obesity, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine therapy in the treatment of binge eating disorder associated with obesity. Lamotrigine has been approved by the Food and Drug Administration for the treatment of bipolar disorder, but has not been approved for use in the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating Disorder, Obesity
- What is being tested?
- Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will meet DSM-IV-TR criteria for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These criteria are as follows:
- Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
- eating, in discrete period of time (e.g., 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
- a sense of lack of control over eating during the episode (e.g., 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
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- 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, defined by body mass index > 30 kg/m2.
- Men or women, between the ages of 18 and 65.
Who cannot join
- Have current body mass index < 30 kg/m2.
- Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (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 or bipolar disorder, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (63) > 24 or a Young Mania Rating Scale (YMRS) (64) > 8.
- A current or recent (within 6 months of the start of study medication) DSM-IV-TR diagnosis of substance abuse or dependence.
- A lifetime history of a DSM-IV-TR psychotic disorder or dementia.
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- History of a personality disorder (e.g., 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.
- 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 lamotrigine.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lamotrigine in the Treatment of Binge Eating Disorder Associated With Obesity: A Single-Center, Double-Blind, Placebo-Controlled, Flexible-Dose Study in Outpatients
This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine therapy in the treatment of binge eating disorder associated with obesity.
Lamotrigine has been approved by the Food and Drug Administration for the treatment of bipolar disorder, but has not been approved for use in the treatment of binge eating disorder with obesity.
Read the detailed description
This is a 17-week, parallel group, placebo-controlled, randomized, double-blind, flexible-dose, single-center study. It begins with a 1 to 2 week screening period during which there will be washout of other medications and evaluation of protocol-specified criteria. The screening period will consist of at least two visits, which will include the initial screening visit and the baseline (week 1) visit. The treatment period follows the screening period and will last 16 weeks. Once a subject enters the treatment phase (after randomization) the dosage of study medication will be 25 mg/qHS (or one placebo tablet at night) for 14 days. On day 14 (visit 2 or the beginning of week 3), the dosage will be increased, as tolerated, to 25 mg b.i.d. On day 28 (visit 4 or in the beginning of week 5), the dosage will be increased, as tolerated, to 50 mg b.i.d. On day 35 (visit 5 or the beginning of week 6), the dosage will be increased, as tolerated, to 100 mg b.i.d. The dosage may be decreased at any time because of side effects. If the patient prefers, he or she may take all of his or her daily dose of medication in the morning or evening. If no response or an inadequate response (< 50% reduction in binge eating episodes compared with baseline) is evident by week 6 (visit 6), study medication may be increased to 150 mg b.i.d. If no response or an inadequate response is evident by week 8 (visit 7), study medication may be increased to 200 mg b.i.d. During weeks 12 through 16 (maintenance period) the dosage will not be changed unless a medical reason (e.g., adverse effect) requires such a change. The minimum dosage allowed will be 50 mg/day and the maximum dosage allowed will be 400 mg/day. The 16-week treatment period will be followed by medication discontinuation and evaluation 1 week after medication discontinuation (week 17). Efficacy and safety evaluations will be done at each visit starting with the baseline visit through week 17 (baseline, weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16).
- Conditions
- Binge Eating Disorder, Obesity
- Being tested
- Lamotrigine, placebo
- Keywords
- Binge Eating Disorder Associated with Obesity
- Medical subject headings
- Binge-Eating Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
25 mg or 100 mg
placeboDrug
identical tablets to study drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lamotrigine Receives: Drug: Lamotrigine |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aims of this study are to examine the efficacy and safety of lamotrigine compared with placebo in outpatients with binge eating disorder associated with obesity.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2009
- Study completionJan 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 DisorderStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University of Cincinnati
- Investigators
- Susan L. McElroy, MD, Principal investigator, Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277641
- Sponsor's protocol ID
- 106531
- Status last verified
- Jun 2011
- First submitted
- 12 Jan 2006
- Last updated
- 22 Jun 2011
- Results posted
- No
Publications
Guerdjikova AI, McElroy SL, Welge JA, Nelson E, Keck PE, Hudson JI. Lamotrigine in the treatment of binge-eating disorder with obesity: a randomized, placebo-controlled monotherapy trial. Int Clin Psychopharmacol. 2009 May;24(3):150-8. doi: 10.1097/YIC.0b013e328329c7b5.
PubMed 19357528
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
- Lamotrigine 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
- NCT00277641
- Acronym / sponsor ID
- 106531
- Conditions
- Binge Eating Disorder, Obesity
- Keywords
- Binge Eating Disorder Associated with Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University of Cincinnati
- Study start
- Mar 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Jan 2006 (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.
This research study is to evaluate the effectiveness, tolerability, and safety of lamotrigine therapy in the treatment of binge eating disorder associated with obesity.
Lamotrigine has been approved by the Food and Drug Administration for the treatment of bipolar disorder, but has not been approved for use in the treatment of binge eating disorder with obesity.
Detailed description
This is a 17-week, parallel group, placebo-controlled, randomized, double-blind, flexible-dose, single-center study. It begins with a 1 to 2 week screening period during which there will be washout of other medications and evaluation of protocol-specified criteria. The screening period will consist of at least two visits, which will include the initial screening visit and the baseline (week 1) visit. The treatment period follows the screening period and will last 16 weeks. Once a subject enters the treatment phase (after randomization) the dosage of study medication will be 25 mg/qHS (or one placebo tablet at night) for 14 days. On day 14 (visit 2 or the beginning of week 3), the dosage will be increased, as tolerated, to 25 mg b.i.d. On day 28 (visit 4 or in the beginning of week 5), the dosage will be increased, as tolerated, to 50 mg b.i.d. On day 35 (visit 5 or the beginning of week 6), the dosage will be increased, as tolerated, to 100 mg b.i.d. The dosage may be decreased at any time because of side effects. If the patient prefers, he or she may take all of his or her daily dose of medication in the morning or evening. If no response or an inadequate response (< 50% reduction in binge eating episodes compared with baseline) is evident by week 6 (visit 6), study medication may be increased to 150 mg b.i.d. If no response or an inadequate response is evident by week 8 (visit 7), study medication may be increased to 200 mg b.i.d. During weeks 12 through 16 (maintenance period) the dosage will not be changed unless a medical reason (e.g., adverse effect) requires such a change. The minimum dosage allowed will be 50 mg/day and the maximum dosage allowed will be 400 mg/day. The 16-week treatment period will be followed by medication discontinuation and evaluation 1 week after medication discontinuation (week 17). Efficacy and safety evaluations will be done at each visit starting with the baseline visit through week 17 (baseline, weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16).
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 |
|---|---|---|
| 1 | Experimental | Drug: Lamotriginelamotrigine |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients will meet DSM-IV-TR criteria for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These criteria are as follows:
- Obesity, defined by body mass index > 30 kg/m2.
- Men or women, between the ages of 18 and 65.
Key exclusion criteria (14 listed)
- Have current body mass index < 30 kg/m2.
- Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (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 or bipolar disorder, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (63) > 24 or a Young Mania Rating Scale (YMRS) (64) > 8.
- A current or recent (within 6 months of the start of study medication) DSM-IV-TR 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 |
|---|---|---|
| Lamotrigine25 mg or 100 mg | Drug | 1 |
| placeboidentical tablets to study drug | Drug | 2 |
Primary outcome
The specific aims of this study are to examine the efficacy and safety of lamotrigine compared with placebo in outpatients with binge eating disorder associated with obesity.
Time frame: 17 weeks
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 19357528Guerdjikova AI, McElroy SL, Welge JA, Nelson E, Keck PE, Hudson JI. Lamotrigine in the treatment of binge-eating disorder with obesity: a randomized, placebo-controlled monotherapy trial. Int Clin Psychopharmacol. 2009 May;24(3):150-8. doi: 10.1097/YIC.0b013e328329c7b5.
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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
Lindner Center of HOPE
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 Lamotrigine in people with Binge Eating Disorder and 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 15 inclusion and 14 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?
The specific aims of this study are to examine the efficacy and safety of lamotrigine compared with placebo in outpatients with binge eating disorder associated with obesity. (time frame: 17 weeks). 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 NCT00277641, 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.