Binge Eating DisorderPhase 2/3NCT00514995
Sodium Oxybate in the Treatment of Binge Eating Disorder
A Phase 2/3 study testing Sodium Oxybate 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 study the effectiveness, tolerability and safety of sodium oxybate in outpatients with binge eating disorder. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Sodium Oxybate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Apr 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 21 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) (72) and supported by the Eating Disorder Examination (EDE) (73). 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 (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
- 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
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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.
- Men or women, from the ages of 21 through 65 years.
- Female subjects must either:
- be incapable of pregnancy because of hysterectomy or tubal ligation.
- if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier methods) for at least 1 month before study entry and agree to continue the use of one of these contraception methods for the duration of the study.
- if sexually abstinent and capable of pregnancy, agree to continue abstinence or to use an acceptable method of birth control (either hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier method) should sexual activity commence.
Who cannot join
- Have a current body mass index < 18kg/m2 or > 40kg/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 current clinically significant depressive symptoms, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (74) > 1324, or a major depressive episode by DSM-IV-TR criteria (1).
- Subjects who have a current or past history of clinically significant suicidality (as determined by psychiatric history, SCID interview, and MADRS suicide item #10) Subjects who have made > 1 lifetime suicide attempt and those with a MADRS suicide item score > 2 will be excluded from participation.
- Subjects who have a lifetime history of a DSM-IV-TR diagnosis of a substance abuse or dependence disorder, except for nicotine abuse or dependence (as determined by psychiatric history, SCID interview, and urine toxicology; see below).
- Subjects who have a lifetime history of a DSM-IV-TR psychotic disorder, bipolar disorder, or dementia.
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- Subjects who have a 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 with sodium oxybate. Patients should be biochemically euthyroid prior to entering the study.
- History of obstructive sleep apnea (OBS) or receiving a high risk score for OBS on the Berlin Questionnaire (75).
- 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, drugs with CNS depressant effects).
- Subjects who have received any psychoactive medication 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 sodium oxybate.
- 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
The purpose of this research study is to study the effectiveness, tolerability and safety of sodium oxybate in outpatients with binge eating disorder.
- Conditions
- Binge Eating Disorder
- Being tested
- Sodium Oxybate
- 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.
Sodium OxybateDrug
4.5 g/night - 9 g/night, liquid taken twice per night
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sodium Oxybate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the weekly frequency of binge-eating episodes (binge frequency).
Measured: 16 weeks
Secondary outcomes (1)
Secondary outcome measures will include weekly frequency of binge days; body mass index; CGI-severity scores; YBOCS-BE modified for Binge Eating scores; Eating Inventory scores; and MADRS total scores.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionApr 2011
- Study completionApr 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals, University of Cincinnati
- Investigators
- Susan L. McElroy, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514995
- Sponsor's protocol ID
- McElroy
- Status last verified
- Jun 2011
- First submitted
- 8 Aug 2007
- Last updated
- 22 Jun 2011
- Results posted
- No
Publications
McElroy SL, Guerdjikova AI, Winstanley EL, O'Melia AM, Mori N, Keck PE Jr, Hudson JI. Sodium oxybate in the treatment of binge eating disorder: an open-label, prospective study. Int J Eat Disord. 2011 Apr;44(3):262-8. doi: 10.1002/eat.20798.
PubMed 20209489
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
- Sodium Oxybate in the Treatment of Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT00514995
- Acronym / sponsor ID
- McElroy
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals, University of Cincinnati
- Study start
- Aug 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 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 study the effectiveness, tolerability and safety of sodium oxybate in outpatients with binge eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sodium Oxybate |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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) (72) and supported by the Eating Disorder Examination (EDE) (73). These criteria are as follows:
- Men or women, from the ages of 21 through 65 years.
- Female subjects must either:
Key exclusion criteria (14 listed)
- Have a current body mass index < 18kg/m2 or > 40kg/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 current clinically significant depressive symptoms, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (74) > 1324, or a major depressive episode by DSM-IV-TR criteria (1).
- Subjects who have a current or past history of clinically significant suicidality (as determined by psychiatric history, SCID interview, and MADRS suicide item #10) Subjects who have made > 1 lifetime suicide attempt and those with a MADRS suicide item score > 2 will be excluded from participation.
- Subjects who have a lifetime history of a DSM-IV-TR diagnosis of a substance abuse or dependence disorder, except for nicotine abuse or dependence (as determined by psychiatric history, SCID interview, and urine toxicology; see below).
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 |
|---|---|---|
| Sodium Oxybate4.5 g/night - 9 g/night, liquid taken twice per night | Drug | 1 |
Primary outcome
The primary outcome measure will be the weekly frequency of binge-eating episodes (binge frequency).
Time frame: 16 weeks
1 secondary outcome
Secondary outcome measures will include weekly frequency of binge days; body mass index; CGI-severity scores; YBOCS-BE modified for Binge Eating scores; Eating Inventory scores; and MADRS total scores.
Time frame: 18 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 20209489McElroy SL, Guerdjikova AI, Winstanley EL, O'Melia AM, Mori N, Keck PE Jr, Hudson JI. Sodium oxybate in the treatment of binge eating disorder: an open-label, prospective study. Int J Eat Disord. 2011 Apr;44(3):262-8. doi: 10.1002/eat.20798.
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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 2/3 study testing Sodium Oxybate 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 18 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. 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 outcome measure will be the weekly frequency of binge-eating episodes (binge frequency). (time frame: 16 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 NCT00514995, 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.