Binge Eating DisorderPhase 2NCT02659488
Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects
A Phase 2 study testing Lisdexamfetamine in people with Binge Eating Disorder, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Lisdexamfetamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2017
- Phase
- Phase 2
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lindner Center of HOPE
Mason, Ohio, 45040
Anna Guerdjikova, PhD,LISW, 513-536-0700
Susan L. McElroy, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Binge Eating Disorder
- Being tested
- Lisdexamfetamine
- 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.
LisdexamfetamineDrug
Also called Vyvanse
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
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine | Other | 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. Receives: Drug: Lisdexamfetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
Measured: Change from baseline to 12 weeks of brain activation
Secondary outcomes (4)
Clinical Global Impression Improvement Scale (CGI-I)
score between 1-7 (1 = very much improved, ranging to 7 = very much worse)
Measured: weeks 1, 2, 3, 4, 6, 8, 10, 12
Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)
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.
Measured: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Binge Eating Scale (BES)
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.
Measured: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Weight
measured in kilograms
Measured: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Susan L McEroy, MD, Principal investigator, Lindner Center of HOPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659488
- Sponsor's protocol ID
- 2015-2882
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study will be published in a peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02659488
- Acronym / sponsor ID
- 2015-2882
- Conditions
- Binge Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jan 2016 (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 explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine | Other | Drug: LisdexamfetamineDuring 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 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. 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.
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 |
|---|---|---|
| LisdexamfetamineAlso: Vyvanse20 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 | Drug | Lisdexamfetamine |
Primary outcome
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
Time frame: Change from baseline to 12 weeks of brain activation
Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
4 secondary outcomes
Clinical Global Impression Improvement Scale (CGI-I)
Time frame: weeks 1, 2, 3, 4, 6, 8, 10, 12
Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Binge Eating Scale (BES)
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Weight
Time frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Individual participant dataSharing planned: Yes. Study will be published in a peer-reviewed journal
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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 McEroy, MD principal investigator
Lindner Center of HOPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lisdexamfetamine 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 0 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Guerdjikova, PhD, LISW (513-536-0700, anna.guerdjikova@lindnercenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues. (time frame: Change from baseline to 12 weeks of brain activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.