Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
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|ClinicalTrials.gov Identifier: NCT03924193|
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Binge-Eating Disorder Obesity||Drug: Lisdexamfetamine Dimesylate Behavioral: Cognitive-Behavioral Therapy Other: Combination LDX and Cognitive-Behavioral Therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity|
|Actual Study Start Date :||March 25, 2019|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
|Active Comparator: LDX||
Drug: Lisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
|Active Comparator: Cognitive-Behavioral Therapy||
Behavioral: Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
|Active Comparator: LDX and Cognitive Behavioral Therapy||
Other: Combination LDX and Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
- Binge-Eating Frequency [ Time Frame: Post-treatment (3 months) ]Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
- Body Mass Index [ Time Frame: Post-treatment (3 months) ]BMI is calculated using measured height and weight (e.g., percent loss).
- Binge-Eating Remission [ Time Frame: Post-treatment (3 months) ]Categorical: zero binges/28 days
- Eating-Disorder Psychopathology [ Time Frame: Post-treatment (3 months) ]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).
- Depressive Symptoms [ Time Frame: Post-treatment (3 months) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924193
|Contact: Valentina Ivezaj, Ph.D.||firstname.lastname@example.org|
|United States, Connecticut|
|Yale Department of Psychiatry||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Valentina Ivezaj, Ph.D. 203-785-7210 email@example.com|
|Principal Investigator: Carlos M Grilo, Ph.D.|
|Principal Investigator:||Carlos M Grilo, Ph.D.||Yale University|