Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 12:43 PM
Study NCT ID:
NCT04599504
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-07
First Post:
2020-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069478', 'term': 'Lisdexamfetamine Dimesylate'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D003913', 'term': 'Dextroamphetamine'}, {'id': 'D000661', 'term': 'Amphetamine'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loss-of-Control Eating Frequency', 'timeFrame': 'From baseline interview at study enrollment to after the 12-week treatment', 'description': '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.'}, {'measure': 'Loss-of-Control Eating Frequency', 'timeFrame': 'From post-treatment to the 6-month follow-up', 'description': '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.'}, {'measure': 'Loss-of-Control Eating Frequency', 'timeFrame': 'From post-treatment to the 12-month follow-up', 'description': '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.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'From baseline at study enrollment to after the 12-week treatment', 'description': 'BMI is calculated using measured height and weight'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'From post-treatment to the 6-month follow-up', 'description': 'BMI is calculated using measured height and weight'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'From post-treatment to the 12-month follow-up', 'description': 'BMI is calculated using measured height and weight'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Loss-of-control Eating', 'Obesity/Overweight']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be in the age range ≥18 years of age and \\<65 years of age.\n* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy\n* Approximately ten months post-surgery\n* 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\n* Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).\n* Read, comprehend, and write English at a sufficient level to complete study-related materials.\n* Provide a signed and dated written informed consent prior to study participation.\n* Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up).\n\nExclusion Criteria:\n\n* 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).\n* Has a history of anorexia nervosa or history of bulimia nervosa.\n* Is currently using other medications for weight loss.\n* Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)\n* Has untreated hypertension with a seated systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg, or heart rate \\> 100 beats/minute.\n* Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.\n* Has current uncontrolled hypertension.\n* Has current uncontrolled Type I or Type II diabetes mellitus.\n* 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.\n* Has gallbladder disease.\n* Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.\n* Is currently in active treatment for eating or weight loss.\n* 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.\n* Is breast-feeding or is pregnant or is not using a reliable form of birth control.\n* Reports active suicidal or homicidal ideation.\n* Previous history of problems with LDX or other stimulants.\n* Has a history of allergy or sensitivity to LDX or other stimulant medications.\n* Current medication contraindicated with study medication.\n* Any current psychostimulant use or any medication for ADHD.\n* History or current alcohol or substance use disorder (smoking will not be exclusionary)\n* Is currently taking MAOI medication, SSRI medication, or strong inhibitors of CYP2D6'}, 'identificationModule': {'nctId': 'NCT04599504', 'briefTitle': 'Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)', 'orgStudyIdInfo': {'id': '2000029057b'}, 'secondaryIdInfos': [{'id': '5R01DK126637-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01DK126637-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lisdexamfetamine dimesylate', 'interventionNames': ['Drug: Lisdexamfetamine Dimesylate (Medication)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lisdexamfetamine Dimesylate (Medication)', 'type': 'DRUG', 'otherNames': ['Vyvanse'], 'description': 'Medication will be taken daily in pill form.', 'armGroupLabels': ['Lisdexamfetamine dimesylate']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be inactive and taken daily in pill form.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Carlos Grilo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}