Binge Eating DisorderPhase 3NCT01010789
Armodafinil in Binge Eating Disorder (BED)
A Phase 3 study testing Armodafinil in people with Binge Eating Disorder and Overweight, 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 armodafinil in outpatients 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, Overweight, Obese
- What is being tested?
- Armodafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 2015
- 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
- Inclusion Criteria: Criteria for entering this study will include all of the following:
- Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV-TR 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 (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 conditions; and 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; 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.
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- The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
- In addition, subjects will report at least 3 binge eating days per week for the 2 weeks prior to randomization prospectively documented in take-home binge diaries. A binge eating day (or binge day) is a day during which at least one binge eating episode occurs.
- Subjects will have a BMI ≥ 25. The subject population is expected to include overweight and obese individuals.
- Men or women, through the ages of 18 and 65 years, inclusive.
Who cannot join
- Have concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. All female subjects who still have a uterus will have a negative pregnancy test prior to randomization.
- Subjects who are displaying clinically significant suicidality or homicidality.
- Subjects who have begun a new psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers, Overeaters Anonymous) intervention within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes to the frequency or nature of their psychotherapy during the course of the drug trial.
- A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
- A lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia.
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- History of any psychiatric or 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. Subjects should be biochemically euthyroid to enter the study.
- Have a history of any major cardiovascular event in the past 6 months, including unstable angina, acute myocardial infarction, coronary angioplasty, or stroke.
- History of seizures, including clinically febrile seizures in childhood.
- Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110).
- Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation.
- Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
- Subjects who have a known allergy to armodafinil.
- Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine.
- Subjects who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including monoamine oxidase inhibitors, tricyclics, selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, or psychostimulants.
- Subjects who have received investigational medications or depot neuroleptics within three months prior to randomization
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 armodafinil in outpatients with binge eating disorder.
- Conditions
- Binge Eating Disorder, Overweight, Obese
- Being tested
- Armodafinil, Matching placebo
- Medical subject headings
- Binge-Eating Disorder, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
flexible dose 150-250mg/day
ArmodafinilDrug
150-250mg/day; flexible dose
Matching placeboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil | Experimental | Flexible dose 150-250mg/day Receives: Drug: Armodafinil |
| Mathing Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is binge day frequency as assessed by take-home patient diary
Measured: 12 treatment weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2014
- Study completionMay 2015
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010789
- Sponsor's protocol ID
- Cephalon_001
- Status last verified
- May 2015
- First submitted
- 9 Nov 2009
- Last updated
- 14 May 2015
- Results posted
- No
Publications
McElroy SL, Guerdjikova AI, Mori N, Blom TJ, Williams S, Casuto LS, Keck PE Jr. Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jul;30(4):209-15. doi: 10.1097/YIC.0000000000000079.
PubMed 26011779
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Armodafinil in Binge Eating Disorder (BED)
- ClinicalTrials.gov ID
- NCT01010789
- Acronym / sponsor ID
- Cephalon_001
- Conditions
- Binge Eating Disorder, Overweight, Obese
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Cephalon, University of Cincinnati
- Study start
- Nov 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Nov 2009 (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 armodafinil in outpatients with binge eating disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armodafinil | Experimental | Drug: ArmodafinilFlexible dose 150-250mg/day |
| Mathing Placebo | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV-TR criteria are as follows:
- In addition, subjects will report at least 3 binge eating days per week for the 2 weeks prior to randomization prospectively documented in take-home binge diaries. A binge eating day (or binge day) is a day during which at least one binge eating episode occurs.
- Subjects will have a BMI ≥ 25. The subject population is expected to include overweight and obese individuals.
- Men or women, through the ages of 18 and 65 years, inclusive.
Key exclusion criteria (17 listed)
- Have concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. All female subjects who still have a uterus will have a negative pregnancy test prior to randomization.
- Subjects who are displaying clinically significant suicidality or homicidality.
- Subjects who have begun a new psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers, Overeaters Anonymous) intervention within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes to the frequency or nature of their psychotherapy during the course of the drug trial.
- A DSM-IV-TR 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 |
|---|---|---|
| Armodafinilflexible dose 150-250mg/day | Drug | Armodafinil |
| Armodafinil150-250mg/day; flexible dose | Drug | Armodafinil |
| Matching placeboPlacebo comparator | Drug | Mathing Placebo |
Primary outcome
The primary efficacy variable is binge day frequency as assessed by take-home patient diary
Time frame: 12 treatment 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 14 May 2015.
- Derived from this study: PubMed 26011779McElroy SL, Guerdjikova AI, Mori N, Blom TJ, Williams S, Casuto LS, Keck PE Jr. Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jul;30(4):209-15. doi: 10.1097/YIC.0000000000000079.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Armodafinil in people with Binge Eating Disorder and Overweight, 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 10 inclusion and 17 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 14 May 2015. 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 primary efficacy variable is binge day frequency as assessed by take-home patient diary (time frame: 12 treatment 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 NCT01010789, 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 14 May 2015.