Binge Eating DisorderPhase 2/3NCT00511940
Acamprosate in the Treatment of Binge-Eating Disorder
A Phase 2/3 study testing acamprosate in people with Binge Eating Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- acamprosate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jan 2011
- Phase
- Phase 2/3
- 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
- Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:
- Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a 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 conditions; and 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.
- The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
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- In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization
- Weight > 85% of the midpoint of ideal body weight for their height. (According to the Metropolitan Height/Weight table.) The subject population is expected to include both normal weight and obese individuals (although the majority of subjects are expected to be overweight).
- Men or women, between the ages of 18 and 65. The subject population is expected to be predominantly made up of women.
Who cannot join
- Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight loss to at least 15% below the Metropolitan Height/Weight tables.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study).
- Patients who are displaying clinically significant suicidality or homicidality.
- Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for BED for at least 3 months prior to randomization.
- A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
- A lifetime DSM-IV history of psychosis, mania or hypomania, or dementia.
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- History of any psychiatric and personality disorder (eg, schizotypal and borderline) which might interfere with a diagnostic assessment, treatment, or compliance.
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, treatment, or assessment of BED. Patients should be biochemically euthyroid to enter the study.
- History of seizures, including febrile seizures in childhood.
- Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.
- Clinically relevant abnormal laboratory results, specifically including hypokalemia.
- Patients who have received monoamine oxidase inhibitors, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.
- Patients who have received other psychoactive medications (other than hypnotics) within one week prior to randomization.
- Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.
- Patients previously enrolled in this study or have previously been treated with acamprosate.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder.
- Conditions
- Binge Eating Disorder
- Being tested
- acamprosate, placebo
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acamprosateDrug
Also called Campral
999 mg/day - 2997 mg/day, oral
placeboOther
oral, placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | acamprosate Receives: Drug: acamprosate |
| 2 | Placebo comparator | sugar pill Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be change in weekly binge frequency
Measured: 10 weeks
Secondary outcomes (1)
Secondary efficacy variables will include change in binge day frequency (days during which at least one binge occurs), obsessive-compulsive symptoms of BED, craving for food, depressive symptoms, weight, and BMI
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2011
- Study completionJan 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories, University of Cincinnati
- Investigators
- Susan L McElroy, MD, Principal investigator, Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511940
- Sponsor's protocol ID
- CMP-MD-20
- Status last verified
- Jun 2011
- First submitted
- 3 Aug 2007
- Last updated
- 22 Jun 2011
- Results posted
- No
Publications
McElroy SL, Guerdjikova AI, Winstanley EL, O'Melia AM, Mori N, McCoy J, Keck PE Jr, Hudson JI. Acamprosate in the treatment of binge eating disorder: a placebo-controlled trial. Int J Eat Disord. 2011 Jan;44(1):81-90. doi: 10.1002/eat.20876.
PubMed 21080416
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
- Acamprosate in the Treatment of Binge-Eating Disorder
- ClinicalTrials.gov ID
- NCT00511940
- Acronym / sponsor ID
- CMP-MD-20
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Forest Laboratories, University of Cincinnati
- Study start
- Apr 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Aug 2007 (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 purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: acamprosateacamprosate |
| 2 | Placebo comparator | Other: placebosugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:
- In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization
- Weight > 85% of the midpoint of ideal body weight for their height. (According to the Metropolitan Height/Weight table.) The subject population is expected to include both normal weight and obese individuals (although the majority of subjects are expected to be overweight).
- Men or women, between the ages of 18 and 65. The subject population is expected to be predominantly made up of women.
Key exclusion criteria (15 listed)
- Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight loss to at least 15% below the Metropolitan Height/Weight tables.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study).
- Patients who are displaying clinically significant suicidality or homicidality.
- Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for BED for at least 3 months prior to randomization.
- A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
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 |
|---|---|---|
| acamprosateAlso: Campral999 mg/day - 2997 mg/day, oral | Drug | 1 |
| placebooral, placebo | Other | 2 |
Primary outcome
The primary efficacy variable will be change in weekly binge frequency
Time frame: 10 weeks
1 secondary outcome
Secondary efficacy variables will include change in binge day frequency (days during which at least one binge occurs), obsessive-compulsive symptoms of BED, craving for food, depressive symptoms, weight, and BMI
Time frame: 10 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 21080416McElroy SL, Guerdjikova AI, Winstanley EL, O'Melia AM, Mori N, McCoy J, Keck PE Jr, Hudson JI. Acamprosate in the treatment of binge eating disorder: a placebo-controlled trial. Int J Eat Disord. 2011 Jan;44(1):81-90. doi: 10.1002/eat.20876.
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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 2/3 study testing acamprosate in people with Binge Eating Disorder, 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 9 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 primary efficacy variable will be change in weekly binge frequency (time frame: 10 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 NCT00511940, 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.