- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659488
Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects
January 15, 2016 updated by: Lindner Center of HOPE
Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
Study Overview
Detailed Description
12-week, open-label LDX trial for BED including fMRI assessments to test the following specific predictions:
- At baseline, patients with BED will show greater ventral prefrontal, striatal, and amygdala brain activation to high-calorie food pictures (reward) than matched healthy comparison subjects.
- After 12 weeks of LDX treatment, BED will exhibit reduced ventral prefrontal, striatal and amygdala brain activation to food cues compared to baseline.
- BED patients who display cessation of binge eating and those who demonstrate clinical improvement after 12 weeks of LDX treatment will show greater reductions in ventral prefrontal, striatal, and amygdala brain activation to food pictures than patients who do not stop binge eating and those who do not improve, respectively.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Guerdjikova, PhD, LISW
- Phone Number: 513-536-0700
- Email: anna.guerdjikova@lindnercenter.org
Study Locations
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Ohio
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Mason, Ohio, United States, 45040
- Recruiting
- Lindner Center of HOPE
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Contact:
- Anna Guerdjikova, PhD,LISW
- Phone Number: 513-536-0700
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Principal Investigator:
- Susan L. McElroy, MD
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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
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
- Subjects will report at least 3 binge eating (BE) days per week for the two weeks prior to LDX initiation prospectively documented in take-home binge diaries.
- Women, through the ages of 18 and 55 years, inclusive.
- Willingness to receive open-label LDX treatment for 12 weeks.
- Willingness to receive an fMRI before and after 12 weeks of LDX treatment.
Exclusion Criteria:
Criteria for exclusion from this study will include all of the following:
- 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. The following are considered to be adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. a contraceptive implantation system (Norplant); 4. oral contraceptive pills; 5. a surgically sterile patient; and 6. abstinence. All female subjects will have a negative pregnancy test prior to randomization.
- Subjects who are displaying suicidal ideation on the Columbia-Suicide Severity Scale (C-SSRS) (21), or a suicide attempt within the last year as defined by the C-SSRS, or homicidality.
- Subjects who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun 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.
- Subjects who have used psychostimulants to facilitate fasting or dieting as a part of their eating disorder within the past 6 months; patients who have misused psychostimulants within the past 6 months; and patients who have a drug screen at the screening visit positive for psychostimulants.
- A lifetime DSM-IV-TR history of ADHD, psychosis, mania or hypomania, or dementia.
- History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance, or a current Montgomery Asberg Depression Scale (MADRS) (22) score ≥ 18.
- Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease; clinically significant abnormalities on physical exam; or clinically significant laboratory abnormalities. Subjects should be biochemically euthyroid to enter the study.
- Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
- History of seizures, including clinically significant febrile seizures in childhood.
- Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110). m. 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.
- Have a specific medical condition where LDX use is contraindicated, such as narrow angle glaucoma or Tourette's syndrome.
- 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 two weeks prior to LDX initiation, 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 LDX initiation.
- Subjects who have a known allergy to LDX or its constituents
- An MRI scan is contraindicated in the subject for safety reasons, claustrophobia, or if the patient exceeds the weight limit of MRI scanner, ~350 pounds.
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Lisdexamfetamine
During the Treatment Phase, subjects will be evaluated after 1, 2, 3, 4, 6, 8, 10, and 12 weeks (see Figure 2).
The morning after completing the first fMRI scan, LDX will be started at 30 mg q AM (Baseline).
After 1 week, LDX will then be increased to 50 mg q AM (Visit 1); after another week, LDX will be increased to 70 mg q AM (Visit 2).
A single downward dose titration to 50 mg is allowed during week 3 if 70 mg/d is not tolerated.
LDX dose at week 4 (50 or 70 mg/d) will be maintained for the next 8 weeks.
Patients who do not tolerate 50 or 70 mg/day will be terminated.
For patients who complete the 12-week treatment phase, LDX will be stopped at week 12 visit.
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20 healthy controls and 20 women subjects with BED agreeing to a 12-week, open-label trial of LDX and fMRI assessments immediately before and after the 12 weeks of LDX treatment will be recruited
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Time Frame: Change from baseline to 12 weeks of brain activation
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Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
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Change from baseline to 12 weeks of brain activation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Impression Improvement Scale (CGI-I)
Time Frame: weeks 1, 2, 3, 4, 6, 8, 10, 12
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score between 1-7 (1 = very much improved, ranging to 7 = very much worse)
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weeks 1, 2, 3, 4, 6, 8, 10, 12
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Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)
Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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Will examine to see if severity of YBOC-BE scores correlate with fMRI abnormalities at baseline; and whether improvement in this scale with LDX treatment correlate with improvement in fMRI abnormalities at Endpoint.
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weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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Binge Eating Scale (BES)
Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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Will examine to see if severity of BES scores correlate with fMRI abnormalities at baseline; and whether improvement in this scale with LDX treatment correlate with improvement in fMRI abnormalities at Endpoint.
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weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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Weight
Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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measured in kilograms
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weeks 0,1, 2, 3, 4, 6, 8, 10, 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan L McEroy, MD, Lindner Center of HOPE
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
September 1, 2015
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
January 8, 2016
First Submitted That Met QC Criteria
January 15, 2016
First Posted (Estimate)
January 20, 2016
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 15, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Hyperphagia
- Bulimia
- Feeding and Eating Disorders
- Binge-Eating Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Lisdexamfetamine Dimesylate
Other Study ID Numbers
- 2015-2882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study will be published in a peer-reviewed journal
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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