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Trial record 5 of 111 for:    nrp 104 OR lisdexamfetamine

Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects

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ClinicalTrials.gov Identifier: NCT02659488
Recruitment Status : Unknown
Verified January 2016 by Lindner Center of HOPE.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

Brief Summary:
The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: Lisdexamfetamine Phase 2

Detailed Description:

12-week, open-label LDX trial for BED including fMRI assessments to test the following specific predictions:

  1. 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.
  2. After 12 weeks of LDX treatment, BED will exhibit reduced ventral prefrontal, striatal and amygdala brain activation to food cues compared to baseline.
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
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.
Drug: Lisdexamfetamine
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 Name: Vyvanse




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: weeks 1, 2, 3, 4, 6, 8, 10, 12 ]
    score between 1-7 (1 = very much improved, ranging to 7 = very much worse)

  2. Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE) [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]
    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.

  3. Binge Eating Scale (BES) [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]
    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.

  4. Weight [ Time Frame: weeks 0,1, 2, 3, 4, 6, 8, 10, 12 ]
    measured in kilograms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Criteria for entering this study will include all of the following:

  1. Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months.
  2. 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.
  3. Women, through the ages of 18 and 55 years, inclusive.
  4. Willingness to receive open-label LDX treatment for 12 weeks.
  5. 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:

  1. Have concurrent symptoms of bulimia nervosa or anorexia nervosa.
  2. 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.
  3. 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.
  4. 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.
  5. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
  6. 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.
  7. A lifetime DSM-IV-TR history of ADHD, psychosis, mania or hypomania, or dementia.
  8. 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.
  9. 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.
  10. Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
  11. History of seizures, including clinically significant febrile seizures in childhood.
  12. 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.
  13. Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
  14. Have a specific medical condition where LDX use is contraindicated, such as narrow angle glaucoma or Tourette's syndrome.
  15. 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.
  16. 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.
  17. Subjects who have received investigational medications or depot neuroleptics within three months prior to LDX initiation.
  18. Subjects who have a known allergy to LDX or its constituents
  19. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659488


Contacts
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Contact: Anna Guerdjikova, PhD, LISW 513-536-0700 anna.guerdjikova@lindnercenter.org

Locations
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United States, Ohio
Lindner Center of HOPE Recruiting
Mason, Ohio, United States, 45040
Contact: Anna Guerdjikova, PhD,LISW    513-536-0700      
Principal Investigator: Susan L. McElroy, MD         
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati
Investigators
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Principal Investigator: Susan L McEroy, MD Lindner Center of HOPE

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Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT02659488     History of Changes
Other Study ID Numbers: 2015-2882
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study will be published in a peer-reviewed journal
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents