Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects

Binge Eating Disorder Clinical Trial

Official title:

Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659488
• Other study ID #: 2015-2882
• Status: Recruiting
• Phase: Phase 2
• First received: January 8, 2016
• Last updated: January 15, 2016
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Lindner Center of HOPE
• Contact: Anna Guerdjikova, PhD, LISW
• Phone: 513-536-0700
• Email: anna.guerdjikova[@]lindnercenter.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Lindner Center of HOPE	Mason	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Lindner Center of HOPE	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical Global Impression Improvement Scale (CGI-I)	score between 1-7 (1 = very much improved, ranging to 7 = very much worse)	weeks 1, 2, 3, 4, 6, 8, 10, 12	No
Secondary	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.	weeks 0,1, 2, 3, 4, 6, 8, 10, 12	No
Secondary	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.	weeks 0,1, 2, 3, 4, 6, 8, 10, 12	No
Secondary	Weight	measured in kilograms	weeks 0,1, 2, 3, 4, 6, 8, 10, 12	No