Page last updated: 2024-11-07

dextroamphetamine and Binge-Eating Disorder

dextroamphetamine has been researched along with Binge-Eating Disorder in 2 studies

Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.
(S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration.

Binge-Eating Disorder: A disorder associated with three or more of the following: eating until feeling uncomfortably full; eating large amounts of food when not physically hungry; eating much more rapidly than normal; eating alone due to embarrassment; feeling of disgust, DEPRESSION, or guilt after overeating. Criteria includes occurrence on average, at least 2 days a week for 6 months. The binge eating is not associated with the regular use of inappropriate compensatory behavior (i.e. purging, excessive exercise, etc.) and does not co-occur exclusively with BULIMIA NERVOSA or ANOREXIA NERVOSA. (From DSM-IV, 1994)

Research Excerpts

ExcerptRelevanceReference
"Lisdexamfetamine dimesylate (LDX) is the only drug currently approved by the FDA for the treatment of Binge-Eating Disorder (BED), but little is known about the behavioural mechanisms that underpin the efficacy of LDX in treating BED."5.51The effects of lisdexamfetamine dimesylate on eating behaviour and homeostatic, reward and cognitive processes in women with binge-eating symptoms: an experimental medicine study. ( Chamberlain, SR; Dourish, CT; Higgs, S; Martin, E; Qureshi, KL; Rotshtein, P; Schneider, E; Spetter, MS, 2022)
" Safety assessments included treatment-emergent adverse events, vital signs, and change in weight."2.80Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. ( Ferreira-Cornwell, MC; Gao, J; Gasior, M; Hudson, JI; Jonas, J; McElroy, SL; Mitchell, JE; Wang, J; Whitaker, T; Wilfley, D, 2015)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (50.00)24.3611
2020's1 (50.00)2.80

Authors

AuthorsStudies
Schneider, E1
Martin, E1
Rotshtein, P1
Qureshi, KL1
Chamberlain, SR1
Spetter, MS1
Dourish, CT1
Higgs, S1
McElroy, SL1
Hudson, JI1
Mitchell, JE1
Wilfley, D1
Ferreira-Cornwell, MC1
Gao, J1
Wang, J1
Whitaker, T1
Jonas, J1
Gasior, M1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Double-Blind, Placebo-Controlled Study of Vortioxetine in the Treatment of Binge Eating Disorder[NCT02528409]Phase 280 participants (Actual)Interventional2016-06-30Completed
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder[NCT01291173]Phase 2271 participants (Actual)Interventional2011-05-10Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in Number of Binge Eating Episodes

Subjects will report the number of binge eating episodes in the week preceding the final visit (Week 12 of treatment), both to the investigator and via daily eating journals at all 9 visits. The outcome measure was the change in number of episodes from Week 0 (baseline) to the final visit (Week 12). (NCT02528409)
Timeframe: 12 weeks

Interventionbinge eating episodes (Mean)
Placebo.93
Vortioxetine.76

BMI

Assessment of change in patient body mass index over the course of the study (from baseline to the final visit at Week 12). (NCT02528409)
Timeframe: 12 weeks

,
Interventionkg/m^2 (Mean)
Pre-TreatmentPost-Treatment
Placebo36.1936.29
Vortioxetine38.3938.73

Clinical Global Impression Improvement Scale (CGI)

Patient global improvement relative to baseline, with scores ranging from 1-7. Higher scores indicate the patient is doing severely worse than they were at the beginning of treatment. (NCT02528409)
Timeframe: Week 12 (final) visit

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo4.182.79
Vortioxetine4.252.70

Hamilton Anxiety Rating Scale

A clinician-administered assessment of anxiety that will be assessed at all 9 study visits. The scale provides a discrete score that ranges from 0-56, with higher scores indicating more severe anxiety symptoms. (NCT02528409)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo4.131.79
Vortioxetine3.682.72

Hamilton Depression Rating Scale

A clinician-administered assessment of depression that will be assessed at all 8 study visits after the baseline visit. The scale provides a discrete score that ranges from 0-52, with higher scores indicating more severe depressive symptoms. (NCT02528409)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo4.552.06
Vortioxetine4.323.66

Number of Participants With 4-week Cessation From Binge Eating

Subjects will be assessed at 4 weeks to determine cessation of binge eating status. (NCT02528409)
Timeframe: 4 weeks

,
InterventionParticipants (Count of Participants)
No 4-Week Cessation4-Week Cessation
Placebo2710
Vortioxetine2613

Quality of Life Inventory

A self-report assessment of patient perceived quality of life that will be assessed at baseline and final visit. The scale provides a discrete score ranging from -192 to 192, with higher numbers indicating higher subjective quality of life. (NCT02528409)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo39.1346.22
Vortioxetine35.0044.00

Three-Factor Eating Questionnaire

A self-reported measure of binge eating behavior that will be collected at all 9 study visits with scores ranging from 0-51, with higher scores indicating more compulsive eating habits. (NCT02528409)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo7.719.85
Vortioxetine6.929.48

Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating

A clinician-administered scale assessing binge eating severity that will be assessed at all 9 study visits. Scores range from 0-40 with higher scores indicating more severe OCD symptoms. (NCT02528409)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Pre-TreatmentPost-Treatment
Placebo20.1010.44
Vortioxetine20.559.94

4-Week Binge Response

Subjects are free from binge episodes for 4 weeks. (NCT01291173)
Timeframe: Last 28 days on study

InterventionParticipants (Number)
Placebo13
Lisdexamfetamine Dimesylate (SPD489) 30 mg22
Lisdexamfetamine Dimesylate (SPD489) 50 mg27
Lisdexamfetamine Dimesylate (SPD489) 70 mg31

Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11

The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness. (NCT01291173)
Timeframe: Baseline and week 11

Interventionunits on a scale (Least Squares Mean)
Placebo-3.1
Lisdexamfetamine Dimesylate (SPD489) 30 mg-5.8
Lisdexamfetamine Dimesylate (SPD489) 50 mg-5.2
Lisdexamfetamine Dimesylate (SPD489) 70 mg-6.9

Change From Baseline in Binge Eating Scale (BES) Score at Week 11

The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems. (NCT01291173)
Timeframe: Baseline and week 11

Interventionunits on a scale (Least Squares Mean)
Placebo-12.2
Lisdexamfetamine Dimesylate (SPD489) 30 mg-16.1
Lisdexamfetamine Dimesylate (SPD489) 50 mg-17.6
Lisdexamfetamine Dimesylate (SPD489) 70 mg-20.6

Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11

The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety. (NCT01291173)
Timeframe: Baseline and week 11

Interventionunits on a scale (Least Squares Mean)
Placebo-1.5
Lisdexamfetamine Dimesylate (SPD489) 30 mg-0.9
Lisdexamfetamine Dimesylate (SPD489) 50 mg-1.1
Lisdexamfetamine Dimesylate (SPD489) 70 mg-0.6

Change From Baseline in Log Transformed Binge Days Per Week at Week 11

Binge day is defined as a day during which at least 1 binge episode occurs. (NCT01291173)
Timeframe: Baseline and week 11

InterventionLog days (Least Squares Mean)
Placebo-1.23
Lisdexamfetamine Dimesylate (SPD489) 30 mg-1.24
Lisdexamfetamine Dimesylate (SPD489) 50 mg-1.49
Lisdexamfetamine Dimesylate (SPD489) 70 mg-1.57

Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11

MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. (NCT01291173)
Timeframe: Baseline and week 11

Interventionunits on a scale (Least Squares Mean)
Placebo-1.7
Lisdexamfetamine Dimesylate (SPD489) 30 mg-1.9
Lisdexamfetamine Dimesylate (SPD489) 50 mg-1.3
Lisdexamfetamine Dimesylate (SPD489) 70 mg-1.6

Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks

The number of binge episodes per week as assessed by clinical interview based on subject diary. (NCT01291173)
Timeframe: Baseline and up to 11 weeks

InterventionBinge Episodes (Mean)
Placebo-4.07
Lisdexamfetamine Dimesylate (SPD489) 30 mg-4.57
Lisdexamfetamine Dimesylate (SPD489) 50 mg-5.10
Lisdexamfetamine Dimesylate (SPD489) 70 mg-5.09

Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11

The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme. (NCT01291173)
Timeframe: Baseline and week 11

Interventionunits on a scale (Least Squares Mean)
Placebo-12.0
Lisdexamfetamine Dimesylate (SPD489) 30 mg-15.0
Lisdexamfetamine Dimesylate (SPD489) 50 mg-15.3
Lisdexamfetamine Dimesylate (SPD489) 70 mg-17.0

Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. (NCT01291173)
Timeframe: Up to 11 weeks

InterventionPercentage of participants (Number)
Placebo64.5
Lisdexamfetamine Dimesylate (SPD489) 30 mg84.6
Lisdexamfetamine Dimesylate (SPD489) 50 mg90.6
Lisdexamfetamine Dimesylate (SPD489) 70 mg93.7

1-Week Binge Response, Last Observation Carried Forward (LOCF)

The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach. (NCT01291173)
Timeframe: Last 7 days on study

,,,
InterventionParticipants (Number)
1 week remissionMarked responseModerate responseNegative/Minimal response
Lisdexamfetamine Dimesylate (SPD489) 30 mg2820810
Lisdexamfetamine Dimesylate (SPD489) 50 mg332443
Lisdexamfetamine Dimesylate (SPD489) 70 mg352314
Placebo23151311

Change From Baseline in Eating Inventory Score at Week 11

The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger. (NCT01291173)
Timeframe: Baseline and week 11

,,,
Interventionunits on a scale (Least Squares Mean)
Cognitive restraint of eatingDisinhibitionHunger
Lisdexamfetamine Dimesylate (SPD489) 30 mg4.4-5.6-5.3
Lisdexamfetamine Dimesylate (SPD489) 50 mg3.8-6.3-6.0
Lisdexamfetamine Dimesylate (SPD489) 70 mg4.3-7.2-7.8
Placebo2.5-3.8-3.3

Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11

The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health). (NCT01291173)
Timeframe: Baseline and week 11

,,,
Interventionunits on a scale (Least Squares Mean)
Aggregate Physical ScoreAggregate Mental Score
Lisdexamfetamine Dimesylate (SPD489) 30 mg2.65.0
Lisdexamfetamine Dimesylate (SPD489) 50 mg2.45.5
Lisdexamfetamine Dimesylate (SPD489) 70 mg3.94.9
Placebo1.34.9

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT01291173)
Timeframe: Baseline

,,,
InterventionPercentage of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Lisdexamfetamine Dimesylate (SPD489) 30 mg00054.530.312.13.0
Lisdexamfetamine Dimesylate (SPD489) 50 mg003.159.429.76.31.6
Lisdexamfetamine Dimesylate (SPD489) 70 mg01.61.642.947.66.30
Placebo001.656.529.011.31.6

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) (NCT01291173)
Timeframe: up to 11 weeks

,,,
InterventionPercentage of participants (Number)
Normal, not at all illBorderline mentally illMildly illModerately illMarkedly illSeverely illAmong the most extremely ill
Lisdexamfetamine Dimesylate (SPD489) 30 mg55.426.21.513.81.501.5
Lisdexamfetamine Dimesylate (SPD489) 50 mg60.923.46.37.81.600
Lisdexamfetamine Dimesylate (SPD489) 70 mg65.120.611.13.2000
Placebo37.119.412.924.26.500

Trials

2 trials available for dextroamphetamine and Binge-Eating Disorder

ArticleYear
The effects of lisdexamfetamine dimesylate on eating behaviour and homeostatic, reward and cognitive processes in women with binge-eating symptoms: an experimental medicine study.
    Translational psychiatry, 2022, 01-10, Volume: 12, Issue:1

    Topics: Attention Deficit Disorder with Hyperactivity; Binge-Eating Disorder; Biomedical Research; Central N

2022
Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial.
    JAMA psychiatry, 2015, Volume: 72, Issue:3

    Topics: Adult; Binge-Eating Disorder; Dextroamphetamine; Dopamine Uptake Inhibitors; Double-Blind Method; Hu

2015
Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial.
    JAMA psychiatry, 2015, Volume: 72, Issue:3

    Topics: Adult; Binge-Eating Disorder; Dextroamphetamine; Dopamine Uptake Inhibitors; Double-Blind Method; Hu

2015
Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial.
    JAMA psychiatry, 2015, Volume: 72, Issue:3

    Topics: Adult; Binge-Eating Disorder; Dextroamphetamine; Dopamine Uptake Inhibitors; Double-Blind Method; Hu

2015
Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial.
    JAMA psychiatry, 2015, Volume: 72, Issue:3

    Topics: Adult; Binge-Eating Disorder; Dextroamphetamine; Dopamine Uptake Inhibitors; Double-Blind Method; Hu

2015