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)
Excerpt | Relevance | Reference |
---|---|---|
"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." | 5.51 | The 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." | 2.80 | Efficacy 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) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (50.00) | 24.3611 |
2020's | 1 (50.00) | 2.80 |
Authors | Studies |
---|---|
Schneider, E | 1 |
Martin, E | 1 |
Rotshtein, P | 1 |
Qureshi, KL | 1 |
Chamberlain, SR | 1 |
Spetter, MS | 1 |
Dourish, CT | 1 |
Higgs, S | 1 |
McElroy, SL | 1 |
Hudson, JI | 1 |
Mitchell, JE | 1 |
Wilfley, D | 1 |
Ferreira-Cornwell, MC | 1 |
Gao, J | 1 |
Wang, J | 1 |
Whitaker, T | 1 |
Jonas, J | 1 |
Gasior, M | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Double-Blind, Placebo-Controlled Study of Vortioxetine in the Treatment of Binge Eating Disorder[NCT02528409] | Phase 2 | 80 participants (Actual) | Interventional | 2016-06-30 | Completed | ||
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 2 | 271 participants (Actual) | Interventional | 2011-05-10 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
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
Intervention | binge eating episodes (Mean) |
---|---|
Placebo | .93 |
Vortioxetine | .76 |
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
Intervention | kg/m^2 (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 36.19 | 36.29 |
Vortioxetine | 38.39 | 38.73 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 4.18 | 2.79 |
Vortioxetine | 4.25 | 2.70 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 4.13 | 1.79 |
Vortioxetine | 3.68 | 2.72 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 4.55 | 2.06 |
Vortioxetine | 4.32 | 3.66 |
Subjects will be assessed at 4 weeks to determine cessation of binge eating status. (NCT02528409)
Timeframe: 4 weeks
Intervention | Participants (Count of Participants) | |
---|---|---|
No 4-Week Cessation | 4-Week Cessation | |
Placebo | 27 | 10 |
Vortioxetine | 26 | 13 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 39.13 | 46.22 |
Vortioxetine | 35.00 | 44.00 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 7.71 | 9.85 |
Vortioxetine | 6.92 | 9.48 |
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
Intervention | units on a scale (Mean) | |
---|---|---|
Pre-Treatment | Post-Treatment | |
Placebo | 20.10 | 10.44 |
Vortioxetine | 20.55 | 9.94 |
Subjects are free from binge episodes for 4 weeks. (NCT01291173)
Timeframe: Last 28 days on study
Intervention | Participants (Number) |
---|---|
Placebo | 13 |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 22 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 27 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 31 |
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
Intervention | units 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 |
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
Intervention | units 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 |
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
Intervention | units 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 |
Binge day is defined as a day during which at least 1 binge episode occurs. (NCT01291173)
Timeframe: Baseline and week 11
Intervention | Log 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 |
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
Intervention | units 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 |
The number of binge episodes per week as assessed by clinical interview based on subject diary. (NCT01291173)
Timeframe: Baseline and up to 11 weeks
Intervention | Binge 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 |
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
Intervention | units 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 |
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
Intervention | Percentage of participants (Number) |
---|---|
Placebo | 64.5 |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 84.6 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 90.6 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 93.7 |
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
Intervention | Participants (Number) | |||
---|---|---|---|---|
1 week remission | Marked response | Moderate response | Negative/Minimal response | |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 28 | 20 | 8 | 10 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 33 | 24 | 4 | 3 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 35 | 23 | 1 | 4 |
Placebo | 23 | 15 | 13 | 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
Intervention | units on a scale (Least Squares Mean) | ||
---|---|---|---|
Cognitive restraint of eating | Disinhibition | Hunger | |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 4.4 | -5.6 | -5.3 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 3.8 | -6.3 | -6.0 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 4.3 | -7.2 | -7.8 |
Placebo | 2.5 | -3.8 | -3.3 |
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
Intervention | units on a scale (Least Squares Mean) | |
---|---|---|
Aggregate Physical Score | Aggregate Mental Score | |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 2.6 | 5.0 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 2.4 | 5.5 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 3.9 | 4.9 |
Placebo | 1.3 | 4.9 |
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
Intervention | Percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 0 | 0 | 0 | 54.5 | 30.3 | 12.1 | 3.0 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 0 | 0 | 3.1 | 59.4 | 29.7 | 6.3 | 1.6 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 0 | 1.6 | 1.6 | 42.9 | 47.6 | 6.3 | 0 |
Placebo | 0 | 0 | 1.6 | 56.5 | 29.0 | 11.3 | 1.6 |
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
Intervention | Percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Normal, not at all ill | Borderline mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | |
Lisdexamfetamine Dimesylate (SPD489) 30 mg | 55.4 | 26.2 | 1.5 | 13.8 | 1.5 | 0 | 1.5 |
Lisdexamfetamine Dimesylate (SPD489) 50 mg | 60.9 | 23.4 | 6.3 | 7.8 | 1.6 | 0 | 0 |
Lisdexamfetamine Dimesylate (SPD489) 70 mg | 65.1 | 20.6 | 11.1 | 3.2 | 0 | 0 | 0 |
Placebo | 37.1 | 19.4 | 12.9 | 24.2 | 6.5 | 0 | 0 |
2 trials available for dextroamphetamine and Binge-Eating Disorder
Article | Year |
---|---|
The effects of lisdexamfetamine dimesylate on eating behaviour and homeostatic, reward and cognitive processes in women with binge-eating symptoms: an experimental medicine study.
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.
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.
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.
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.
Topics: Adult; Binge-Eating Disorder; Dextroamphetamine; Dopamine Uptake Inhibitors; Double-Blind Method; Hu | 2015 |