- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010789
Armodafinil in Binge Eating Disorder (BED)
May 13, 2015 updated by: Lindner Center of HOPE
The purpose of this research study is to study the effectiveness, tolerability and safety of armodafinil in outpatients with binge eating disorder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Mason, Ohio, United States
- Lindner Center of HOPE
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Armodafinil
Flexible dose 150-250mg/day
|
flexible dose 150-250mg/day
150-250mg/day; flexible dose
|
Placebo Comparator: Mathing Placebo
|
Placebo comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy variable is binge day frequency as assessed by take-home patient diary
Time Frame: 12 treatment weeks
|
12 treatment weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
May 14, 2015
Last Update Submitted That Met QC Criteria
May 13, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Body Weight
- Hyperphagia
- Bulimia
- Feeding and Eating Disorders
- Binge-Eating Disorder
- Overweight
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- Cephalon_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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