Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects

NCT02659488 | Unknown Phase 2

• 1 other identifier: 2015-2882
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 12 weeks of brain activation

Secondary Outcomes (4)

• Clinical Global Impression Improvement Scale (CGI-I)

  weeks 1, 2, 3, 4, 6, 8, 10, 12

• Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)

  weeks 0,1, 2, 3, 4, 6, 8, 10, 12

• Binge Eating Scale (BES)

  weeks 0,1, 2, 3, 4, 6, 8, 10, 12

• Weight

  weeks 0,1, 2, 3, 4, 6, 8, 10, 12

Study Arms (1)

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.

Drug: Lisdexamfetamine

Interventions

Lisdexamfetamine DRUG

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

Also known as: Vyvanse

Lisdexamfetamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• University of Cincinnati: collaborator

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Susan L McEroy, MD

  Lindner Center of HOPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Guerdjikova, PhD, LISW

CONTACT

513-536-0700; anna.guerdjikova@lindnercenter.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 20, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 20, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)