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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03926052
Recruitment Status Recruiting
First Posted April 24, 2019
Last update posted January 14, 2021
This study will test the effectiveness of lisdexamfetamine (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, LDX medication results in superior maintenance and longer-term outcomes compared with placebo.
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide findings from a controlled test, amongst responders to acute treatments, whether LDX medication results in superior maintenance and longer-term outcomes than placebo. This is one of the few RCTs for BED of medication with follow-up after medication discontinuation.
|Active Comparator: LDX
Drug: Lisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|Placebo Comparator: Placebo
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 18 to 64 years old
- Meets DSM-5 criteria for binge-eating disorder
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50 - Medically cleared as determined by EKG and medical record review - Available for the duration of the treatment and follow-up (18 months) - Read, comprehend, and write English at a sufficient level to complete study-related materials - Able to travel to study location (New Haven, CT) for weekly visits Exclusion Criteria: - Previous history of problems with LDX or other stimulants - Current psychostimulant use or use of any medication for ADHD - Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave - History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems. - History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder. - Current uncontrolled hypertension - Current uncontrolled type I or II diabetes mellitus - Current uncontrolled thyroid illness - Gallbladder disease - Co-occurring severe mental illness requiring hospitalization or intensive treatment - Endorses current active suicidal or homicidal ideation with intent or plan - History or current alcohol or substance use disorder (smoking is not exclusionary) - Predisposition to seizures - History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting - Currently taking MAOI, SSRI or strong inhibitors of CYP2D6 - History of allergy or sensitivity to the study medication or stimulant medications - Current use of medications contraindicated with the study medications - Currently breast feeding or pregnant, or not willing to use reliable form of contraception - Currently taking opioid pain medications or drugs - Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss - Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device - Medical status judged by study physician as contraindication
Contact: Valentina Ivezaj, Ph.D. 203-785-7210 firstname.lastname@example.org
United States, Connecticut
Yale Department of Psychiatry
Principal Investigator: Carlos M Grilo, Ph.D. Yale University