Binge-Eating Disorder, Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
BEHAVIORALCognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
OTHERCombination LDX and Cognitive-Behavioral Therapy
Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Post-treatment (3 months) | 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. |
| Binge-Eating Frequency | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge-Eating Remission | Post-treatment (3 months) | Categorical: zero binges/28 days |
| Eating-Disorder Psychopathology | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. | 47 |
| Cognitive-Behavioral Therapy Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy | 47 |
| LDX and Cognitive Behavioral Therapy Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy | 47 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 0 | 10 |
| Overall Study | Withdrawal by Subject | 5 | 10 | 2 |
Baseline characteristics
| Characteristic | Lisdexamfetamine Dimesylate (LDX) | Total | LDX and Cognitive Behavioral Therapy | Cognitive-Behavioral Therapy |
|---|---|---|---|---|
| Age, Continuous | 44.85 Years STANDARD_DEVIATION 11 | 43.55 Years STANDARD_DEVIATION 11.51 | 44.0 Years STANDARD_DEVIATION 10.8 | 41.40 Years STANDARD_DEVIATION 12.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 19 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 107 Participants | 35 Participants | 36 Participants |
| Region of Enrollment United States | 47 participants | 141 participants | 47 participants | 47 participants |
| Sex: Female, Male Female | 39 Participants | 118 Participants | 37 Participants | 42 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 46 / 47 | 0 / 0 | 46 / 47 |
| serious Total, serious adverse events | 1 / 47 | 0 / 47 | 0 / 47 |
Outcome results
Primary
Binge-Eating Frequency
Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: Post-treatment (3 months)
Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Binge-Eating Frequency | 2.95 Binge-eating episodes (past 28 days) | Standard Deviation 6.04 |
| Cognitive-Behavioral Therapy | Binge-Eating Frequency | 2.33 Binge-eating episodes (past 28 days) | Standard Deviation 5.88 |
| LDX and Cognitive Behavioral Therapy | Binge-Eating Frequency | 0.96 Binge-eating episodes (past 28 days) | Standard Deviation 2.67 |
Primary
Body Mass Index
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.
Time frame: Post-treatment (3 months)
Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Body Mass Index | -5.49 percentage of change in weight | Standard Deviation 3.47 |
| Cognitive-Behavioral Therapy | Body Mass Index | -0.50 percentage of change in weight | Standard Deviation 2.7 |
| LDX and Cognitive Behavioral Therapy | Body Mass Index | -4.76 percentage of change in weight | Standard Deviation 3.57 |
Secondary
Binge-Eating Remission
Categorical: zero binges/28 days
Time frame: Post-treatment (3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Binge-Eating Remission | 19 Participants |
| Cognitive-Behavioral Therapy | Binge-Eating Remission | 21 Participants |
| LDX and Cognitive Behavioral Therapy | Binge-Eating Remission | 33 Participants |
Secondary
Depressive Symptoms
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).
Time frame: Post-treatment (3 months)
Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Depressive Symptoms | 8.24 scores on a scale ranging from 0-63 | Standard Deviation 7.57 |
| Cognitive-Behavioral Therapy | Depressive Symptoms | 10.97 scores on a scale ranging from 0-63 | Standard Deviation 10.26 |
| LDX and Cognitive Behavioral Therapy | Depressive Symptoms | 7.02 scores on a scale ranging from 0-63 | Standard Deviation 7.39 |
Secondary
Eating-Disorder Psychopathology
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).
Time frame: Post-treatment (3 months)
Population: Any instance with a smaller N than specified in the participant flow table and footnote indicates a missing data point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Eating-Disorder Psychopathology | 1.62 scores on a scale ranging from 0-6 | Standard Deviation 0.94 |
| Cognitive-Behavioral Therapy | Eating-Disorder Psychopathology | 1.89 scores on a scale ranging from 0-6 | Standard Deviation 0.97 |
| LDX and Cognitive Behavioral Therapy | Eating-Disorder Psychopathology | 1.07 scores on a scale ranging from 0-6 | Standard Deviation 0.68 |