Binge Eating DisorderPhase 3NCT00402584
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
A Phase 3 study testing sibutramine in people with Binge Eating Disorder and Obesity, run by Abbott.
Trial summary
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects 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, Obesity
- What is being tested?
- sibutramine
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to not given
- 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
- Participants were men and women
- between the ages of 18 and 65
- with Body Mass Index (BMI) <45 kg/m2
- who met DSM-IV criteria for BED
Who cannot join
- Participants were excluded
- for blood pressure >140/90 mm Hg
- with pulse >95 beats/min
- history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
- use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
- current participation in a weight loss program
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- surgical treatment for obesity
- bulimia nervosa or purging in the past 6 months
- alcohol or drug abuse in the past 12 months
- current psychiatric condition being treated with a psychoactive agent
- current major depressive disorder
- history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts
- psychotherapy within the previous 2 months
- Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.
- Conditions
- Binge Eating Disorder, Obesity
- Being tested
- sibutramine
- 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.
sibutramineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Measured: 6 months
Secondary outcomes (6)
Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)
Measured: 6 months
Change from baseline in Body Weight
Measured: 6 months
Change from baseline in BMI
Measured: 6 months
Change from baseline in global improvement
Measured: 6 months
Change from baseline in eating pathology (TFEQ)
Measured: 6 months
Change from baseline in quality of life (IWQOL-Lite).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startAug 2000
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Bacher, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402584
- Sponsor's protocol ID
- SB237
- Status last verified
- Aug 2007
- First submitted
- 20 Nov 2006
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3.
PubMed 18056225
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder
- ClinicalTrials.gov ID
- NCT00402584
- Acronym / sponsor ID
- SB237
- Conditions
- Binge Eating Disorder, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- First posted
- 22 Nov 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.
The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants were men and women
- between the ages of 18 and 65
- with Body Mass Index (BMI) <45 kg/m2
- who met DSM-IV criteria for BED
Key exclusion criteria (14 listed)
- Participants were excluded
- for blood pressure >140/90 mm Hg
- with pulse >95 beats/min
- history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
- use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
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 |
|---|---|---|
| sibutramine | Drug | – |
Primary outcome
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Time frame: 6 months
6 secondary outcomes
Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)
Time frame: 6 months
Change from baseline in Body Weight
Time frame: 6 months
Change from baseline in BMI
Time frame: 6 months
Change from baseline in global improvement
Time frame: 6 months
Change from baseline in eating pathology (TFEQ)
Time frame: 6 months
Change from baseline in quality of life (IWQOL-Lite).
Time frame: 6 months
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 31 Aug 2007.
- Derived from this study: PubMed 18056225Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3.
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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.
Peter Bacher, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sibutramine in people with Binge Eating Disorder and Obesity, run by Abbott.
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 4 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 31 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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 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 frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals (time frame: 6 months). 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 NCT00402584, 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 31 Aug 2007.