Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Loss-of-Control Eating Frequency
Study Overview
Brief Summary
This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following bariatric surgery. This is a controlled test of whether, amongst non-responders to acute treatments, lisdexamfetamine medication results in superior outcomes compared with placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be in the age range ≥18 years of age and <65 years of age.
- •Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- •Approximately ten months post-surgery
- •Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment non-responders to a four-month treatment trial of medication and/or BWL
- •Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
- •Read, comprehend, and write English at a sufficient level to complete study-related materials.
- •Provide a signed and dated written informed consent prior to study participation.
- •Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up).
Exclusion Criteria
- •Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- •Has a history of anorexia nervosa or history of bulimia nervosa.
- •Is currently using other medications for weight loss.
- •Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- •Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute.
- •Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
- •Has current uncontrolled hypertension.
- •Has current uncontrolled Type I or Type II diabetes mellitus.
- •Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
- •Has gallbladder disease.
- •Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
- •Is currently in active treatment for eating or weight loss.
- •Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
- •Is breast-feeding or is pregnant or is not using a reliable form of birth control.
- •Reports active suicidal or homicidal ideation.
- •Previous history of problems with LDX or other stimulants.
- •Has a history of allergy or sensitivity to LDX or other stimulant medications.
- •Current medication contraindicated with study medication.
- •Any current psychostimulant use or any medication for ADHD.
- •History or current alcohol or substance use disorder (smoking will not be exclusionary)
- •Is currently taking MAOI medication, SSRI medication, or strong inhibitors of CYP2D6
Arms & Interventions
Placebo
Intervention: Placebo (Other)
Lisdexamfetamine dimesylate
Intervention: Lisdexamfetamine Dimesylate (Medication) (Drug)
Outcomes
Primary Outcomes
Loss-of-Control Eating Frequency
Time Frame: At the end of 12-week treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Loss-of-Control Eating Frequency
Time Frame: 6-month follow-up from the end of treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Loss-of-Control Eating Frequency
Time Frame: 12-month follow-up from the end of treatment
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
Percent Weight Change
Time Frame: From baseline at study enrollment to after the 12-week treatment
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 3 months. Negative values indicate weight loss.
Percent Weight Change
Time Frame: From post-treatment to the 6-month follow-up
Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss.
Percent Weight Change
Time Frame: From post-treatment to the 12-month follow-up
Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss.
Secondary Outcomes
No secondary outcomes reported