Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 11:01 AM
Study NCT ID:
NCT03924193
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], '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': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'valentina.ivezaj@yale.edu', 'phone': '2037857807', 'title': 'Dr. Valentina Ivezaj', 'organization': 'Yale University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.', 'description': 'Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).', 'eventGroups': [{'id': 'EG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 46, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 46, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Energy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling Jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Heart Rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchy Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Racing Thoughts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth/throat Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes to Thought Patterns', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binge-Eating Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'OG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'OG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '5.88', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '2.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).', 'unitOfMeasure': 'Binge-eating episodes (past 28 days)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.'}, {'type': 'PRIMARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate (LDX):', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'OG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'OG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.49', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '3.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (3 months)', 'description': 'BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain.', 'unitOfMeasure': 'percentage of change in weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.'}, {'type': 'SECONDARY', 'title': 'Binge-Eating Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'OG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'OG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Categorical: zero binges/28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Eating-Disorder Psychopathology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'OG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'OG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '1.07', 'spread': '0.68', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).', 'unitOfMeasure': 'scores on a scale ranging from 0-6', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'OG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'OG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '8.24', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '10.97', 'spread': '10.26', 'groupId': 'OG001'}, {'value': '7.02', 'spread': '7.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).', 'unitOfMeasure': 'scores on a scale ranging from 0-63', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'FG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'FG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Ten LDX participants stopped the treatment but completed the posttreatment assessment.', 'groupId': 'FG000', 'numSubjects': '32'}, {'comment': 'One CBT participant completed treatment but not the posttreatment assessment.', 'groupId': 'FG001', 'numSubjects': '37'}, {'comment': 'Ten LDX and Cognitive Behavioral Therapy participants stopped the treatment but completed the posttreatment assessment.', 'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lisdexamfetamine Dimesylate (LDX)', 'description': 'Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication.'}, {'id': 'BG001', 'title': 'Cognitive-Behavioral Therapy', 'description': 'Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy'}, {'id': 'BG002', 'title': 'LDX and Cognitive Behavioral Therapy', 'description': 'Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.85', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '41.40', 'spread': '12.59', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '10.80', 'groupId': 'BG002'}, {'value': '43.55', 'spread': '11.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-13', 'size': 621328, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-11T16:53', 'hasProtocol': True}, {'date': '2022-06-13', 'size': 243095, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-23T15:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2019-04-17', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-15', 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge-Eating Frequency', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).'}, {'measure': 'Body Mass Index', 'timeFrame': 'Post-treatment (3 months)', 'description': 'BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain.'}], 'secondaryOutcomes': [{'measure': 'Binge-Eating Remission', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Categorical: zero binges/28 days'}, {'measure': 'Eating-Disorder Psychopathology', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Post-treatment (3 months)', 'description': 'Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge-Eating Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40338285', 'type': 'DERIVED', 'citation': 'Yurkow S, Ivezaj V, Pittman B, Grilo CM. Preferences for Lisdexamfetamine vs Cognitive-Behavioral Therapy for Binge-Eating Disorder: Correlates and Outcomes. J Clin Psychiatry. 2025 May 7;86(2):24m15552. doi: 10.4088/JCP.24m15552.'}]}, 'descriptionModule': {'briefSummary': 'Brief Summary: This study will compare the effectiveness of cognitive behavioral therapy (CBT), lisdexamfetamine (LDX), and the combination of CBT and LDX for the treatment of binge-eating disorder in patients with obesity. This is an acute treatment comparing CBT or LDX alone or in combination.', 'detailedDescription': '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. This study examined the effectiveness of two leading but distinct treatments - lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) - alone and in combination, for BED in patients with obesity. LDX is the first and only FDA-approved medication for the treatment of BED and has demonstrated short-term effectiveness relative to placebo. CBT is the best-established psychological treatment, has demonstrated short-term effectiveness and "treatment specificity" (i.e., superiority to a variety of control and active treatments), has shown longer-term superiority to fluoxetine, and longer-term durability of outcomes. N=180 participants with BED and obesity will be randomly assigned to one of three interventions, CBT alone, LDX alone, or CBT combined with LDX. This RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for patients with obesity and BED. No such study has been performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 64 years old\n* Meets DSM-5 criteria for binge-eating disorder\n* BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \\<50\n* Medically cleared as determined by EKG and medical record review\n* Available for the duration of the treatment and follow-up (18 months)\n* Read, comprehend, and write English at a sufficient level to complete study-related materials\n* Able to travel to study location (New Haven, CT) for weekly visits\n\nExclusion Criteria:\n\n* Previous history of problems with LDX or other stimulants\n* Current psychostimulant use or use of any medication for ADHD\n* Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave\n* 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.\n* History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.\n* Current uncontrolled hypertension\n* Current uncontrolled type I or II diabetes mellitus\n* Current uncontrolled thyroid illness\n* Gallbladder disease\n* Co-occurring severe mental illness requiring hospitalization or intensive treatment\n* Endorses current active suicidal or homicidal ideation with intent or plan\n* History or current alcohol or substance use disorder (smoking is not exclusionary)\n* Predisposition to seizures\n* History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting\n* Currently taking MAOI, SSRI or strong inhibitors of CYP2D6\n* History of allergy or sensitivity to the study medication or stimulant medications\n* Current use of medications contraindicated with the study medications\n* Currently breast feeding or pregnant, or not willing to use reliable form of contraception\n* Currently taking opioid pain medications or drugs\n* Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss\n* 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\n* Medical status judged by study physician as contraindication'}, 'identificationModule': {'nctId': 'NCT03924193', 'briefTitle': 'Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity', 'orgStudyIdInfo': {'id': '2000022480_b'}, 'secondaryIdInfos': [{'id': '1R01DK114075-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK114075-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LDX', 'interventionNames': ['Drug: Lisdexamfetamine Dimesylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive-Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LDX and Cognitive Behavioral Therapy', 'interventionNames': ['Other: Combination LDX and Cognitive-Behavioral Therapy']}], 'interventions': [{'name': 'Lisdexamfetamine Dimesylate', 'type': 'DRUG', 'description': 'Participants randomly assigned to this arm will receive 12 weeks of LDX medication.', 'armGroupLabels': ['LDX']}, {'name': 'Cognitive-Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy', 'armGroupLabels': ['Cognitive-Behavioral Therapy']}, {'name': 'Combination LDX and Cognitive-Behavioral Therapy', 'type': 'OTHER', 'description': 'Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy', 'armGroupLabels': ['LDX and Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Department of Psychiatry', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Carlos M Grilo, Ph.D.', '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'}}}}