Back to resultsLisdexamfetamine for Adults With Bulimia Nervosa
Primary Purpose
Bulimia Nervosa
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lisdexamfetamine dimesylate
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Lisdexamfetamine Dimesylate, Lisdexamfetamine, Vyvanse, Eating Disorders, Mental Disorders, Central Nervous System Stimulants, Dextroamphetamine, LDX, Binge Eating, Purging, Bulimia Nervosa
Eligibility Criteria
Inclusion Criteria:
- 18-55 years of age and signed consent
- Diagnosis of moderate to extreme bulimia nervosa (4 or more episodes of compensatory behaviours per week).
- A body mass index (BMI) between 22 and 30 (calculated as kilograms per meters squared).
- Subject is consistently able to swallow a capsule
- If female, not breast feeding and not of child bearing potential (the latter defined as last menstruation at least 24 months prior to baseline, has undergone tubal ligation, and undergone hysterectomy)
- If female of childbearing potential, agree to use a reliable form of birth control and has a negative serum pregnancy test prior to medication initiation.
Exclusion Criteria:
- A comorbid bipolar disorder, psychotic disorder, moderate-severe depression, and/or ADHD using the SCID-4.
- Previous history of anorexia nervosa (e.g., due to the risk of problematic weight loss secondary to stimulant misuse).
- Severly restrictive eating behaviours, defined as routinely (>2 days a week) eating less than 2 meals a day or at the investigator's discretion.
- Clinically meaningful abnormalities in laboratory tests or electrocardiography results (most relevant concerns include electrolyte abnormalities, hypoglycemia, prolonged QTc, hypertension, and tachycardia).
- Personal or family history of cardiovascular disease that could increase the vulnerability to the sympathomimetic effects of stimulants (e.g., structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, advanced arteriosclerosis, or coronary artery disease) or any current symptomatic cardiovascular disease, as determined by the PI, and/or in consultation with cardiologist (as needed).
- Subject has moderate to severe hypertension (>140/90 mmHg).
- Subject is receiving psychotherapy for the treatment of BN.
- Subject is taking or has taken a psychostimulant within the past 3 months.
- Subject is taking another psychotropic medication AND the dose has been changed 4 weeks prior to study medication initiation (e.g., baseline).
- Subject is on an antipsychotic medication (due to opposing mechanism of action).
- A suspected history of substance use disorder in the preceding 6 months or more distant (e.g., severe history of prior stimulant abuse) or a lifetime history of stimulant substance use disorder.
- Subject is taking or has taken a monoamine oxidase inhibitor (MAOI) within the last 14 days or has a hypersensitivity to amphetamine products or other ingredients in LDX.
- Subject is pregnant, plans to become pregnant, or is nursing.
- Subject uses syrup of ipecac to self-induce vomiting.
- Subject is considered a suicide risk.
- Subject has a known allergy to amphetamines, or other non-medical ingredients in LDX, or is sensitive to, is allergic to, or has had a reaction to other stimulant medications.
- Subject has been diagnosed with glaucoma (an eye disease).
- Subject has been diagnosed with hyperthyroidism (an overactive thyroid gland).
- Insufficient knowledge of English.
Sites / Locations
- Nova Scotia Health Authority
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lisdexamfetamine dimesylate
Arm Description
A central nervous system stimulant, specifically, a prodrug of dextro-amphetamine
Outcomes
Primary Outcome Measures
Enrolment rate
Enrolment rate will be defined as the total number of participants enrolled divided by the total enrolment period in months.
Dropout rates
Dropout rate will be defined as the number of patients whose participation was terminated prior to completion of the post-treatment assessment divided by the total number of participants enrolled.
The applicability of eligibility criteria
The applicability of eligibility criteria will be determined by the ratio of participants screened to participants enrolled.
Secondary Outcome Measures
Incidence of serious or other treatment-emergent adverse events (TEAEs)
Subjects will be asked to report TEAEs to the research team and PI.
Change from baseline in weight/body mass index
Subjects will be weighed using a calibrated hospital scale while wearing a hospital gown and no footwear.
Change from baseline in systolic/diastolic blood pressure (mmHg)
Systolic and diastolic blood pressure will be collected by a study investigator at weekly/biweekly visits.
Change from baseline in heart rate (bpm)
Heart rate will be collected by a study investigator at weekly/biweekly visits.
Incidence of abnormal adherence rates
Adherence will be calculated as the number of pills not returned divided by the number of days since the last visit, multiplied by 100 to yield a percentage. Subjects with an adherence rate between 80% and 120% will be considered adherent to treatment.
Incidence of abnormalities in blood analysis
Most relevant concerns for patients with BN taking LDX include electrolyte abnormalities (potassium, sodium, chloride) and hypoglycemia
Incidence of abnormalities in EKG
Most relevant concerns for patients with BN taking LDX include prolonged QTc, hypertension, and tachycardia.
Incidence of thoughts, ideations, and attempts of suicide, as measured by the Columbia-Suicide Severity Rating Scale (Since Last Visit Version)
A clinician-observed measure designed to assess suicidal ideations and suicidal behaviours since the last visit in clinical trials. The scale consists of 4 sections. Section 1 regards suicidal ideation and consists of 5 "yes" or "no" questions. Section 2 regards the intensity of ideation and asks the patient to describe their most severe ideation. In regard to that ideation, the patient then indicates frequency, duration, controllability, deterrents, and reasons for ideation. Section 3 regards suicidal behaviour, and indicates if there has been an actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviour since the last visit. Additionally, there is a section to indicate if there was suicidal behaviour during the assessment or if there was a suicide since the last visit. Section 4 specifies information about actual attempts only (actual lethality/medical damage and potential lethality).
Change from baseline in the number of binge eating episodes per week
Subjects will record the number of binge eating episodes in a food diary, which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit.
Change from baseline in the number of purging episodes per week
Subjects will record the number of self-induced vomiting episodes in a diary which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit.
Change from baseline in the number of binge eating and purging days per week
Binge eating and purging days are defined as having one or more episodes of binge eating or purging in a day, respectively.
Change from baseline in the Eating Disorder Examination Interview scores
A clinician-administered scale that assesses the severity of 4 areas of eating disorder psychopathology over the past 4 weeks (28 days): Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed. A higher score indicates increased severity. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale (i.e., the mean of all subscale items). To obtain a global score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e., the mean of all items). The scale consists of 28 items.
Change from baseline in the Barratt Impulsiveness Scale scores
This 30-item measure assesses the personality/behavioural construct of impulsiveness and is widely accepted as the primary self-report measure of impulsivity. Items are ranked on a 1-4 scale (1 being "rarely/never" and 4 being "almost always/always"). A total score can be calculated using all 30 items. A higher score indicates higher levels of impulsivity.
Change from baseline in Yale-Brown Obsessive Compulsive Scale modified for binge eating (Y-BOCS-BE)
A 10-item, clinician-administered rating scale for measuring the severity of OCD symptoms as they relate to binge eating. A higher score indicates increased severity. An obsessional subtotal can be calculated by adding items 1-5. A compulsion subtotal can be calculated by adding items 6-10. A total score can be calculated by adding all items. This version will be further modified to assess both binge eating and purging behaviours.
Change from baseline in the three subscale scores of the Three-Factor Eating Questionnaire (TFEQ)
A 51-item self-report scale that assesses three areas of eating behaviours: Cognitive restraint of eating, disinhibition, and hunger.
Change from baseline in Clinical Impairment Assessment (CIA) scale scores for measuring ED impairment
A 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features over the past 28 days. Each item is ranked on a 0-3 scale (0 being "not at all" and 3 being "a lot").
Percent of treatment responders (binge and purge response rate)
Responders defined as ≥50% reduction in the number of binge and/ or purge episodes from baseline to the last two preceding weeks of treatment.
Percent of binge and purge remission (binge and purge remission rate)
Cessation defined as 100% reduction in binge and/or purge episodes in the last 28 days of treatment.
Change in Clinical Global Impression - Severity Scale (CGI-S)
A 7-point scale that requires the clinician to rate the severity of the patient's illness at time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Change in the Modified Two-Step Task parameters
As measured by the Modified Two-Step Task. This task examines exploration/exploitation (choice consistency), as well as goal-directed (i.e., model-based) and habitual (i.e., model-free) control.
Change from baseline in the Coping Self-Efficacy Scale (CSES)
A 26-item measure of one's confidence in performing coping behaviors when faced with life challenges.
Change from baseline in the Locus of Control of Behaviour (LCB)
A 17-item measure of the extent to which subjects perceive responsibility for their behaviour.
Change from baseline in Motivation, Confidence, and Readiness for Behaviour Change Questions
A 3-item measure that assesses the perceived value of changing binge eating, confidence in ability to change binge eating, and readiness to change binge eating.
Qualitative Patient Experience Interview
An exploratory interview which aims to collect qualitative information on each patient's experiences with the study medication (i.e., from the patient's perspective, how does the medication affect their eating disorder symptoms?).
Full Information
NCT ID
NCT03397446
First Posted
December 20, 2017
Last Updated
November 25, 2020
Sponsor
Aaron Keshen
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT03397446
Brief Title
Lisdexamfetamine for Adults With Bulimia Nervosa
Official Title
A Feasibility Study to Evaluate Lisdexamfetamine Dimesylate (Vyvanse) in Adults With Bulimia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Loss of resources due to COVID-19 resulted in insufficient funds to complete the trial as planned. However, sufficient data was collected to fulfill the aims of the trial. Discontinuation is not related to the drug, its use, or adverse events.
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
May 19, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aaron Keshen
Collaborators
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The relatively high rates of bulimia nervosa (BN) in attention-deficit/hyperactivity disorder (ADHD) cohorts suggest a relationship between the two disorders. Interestingly, case studies involving this comorbid population have observed improvements in BN symptoms when given psychostimulants for ADHD. Case studies involving BN patents without this comorbidity have also demonstrated BN symptom improvements upon psychostimulant initiation. Recent studies have also found support for the use of lisdexamfetamine dimesylate, a psychostimulant approved for ADHD, for treating moderate to severe binge eating disorder, an eating disorder akin to BN. Given these findings, there is reason to believe that psychostimulants may also be capable of treating bulimia nervosa.
Ultimately, the investigators would like to conduct a large study that examines whether people who are diagnosed with BN will have fewer episodes of binge eating and purging when they are treated with the psychostimulant medication, lisdexamfetamine dimesylate (LDX). However, preliminary data would be helpful prior to undertaking such a large project. To this end, the aim of the current study is to learn more about a) enrolment rates, b) dropout rates, c) the applicability of our eligibility criteria, d) the potential effects of LDX on novel outcome measures for studying decision-making in BN, e) preliminary safety data, and f) estimates of treatment effect.
Participants (n = 30) will be instructed to take LDX once daily for two months while undergoing routine testing and monitoring to gather preliminary safety and treatment data. The research will take place at the Nova Scotia Health Authority Eating Disorder Clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
Lisdexamfetamine Dimesylate, Lisdexamfetamine, Vyvanse, Eating Disorders, Mental Disorders, Central Nervous System Stimulants, Dextroamphetamine, LDX, Binge Eating, Purging, Bulimia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Participants will be instructed to take LDX once daily for two months. The trial will begin with a 4-week titration period followed by a 4-week maintenance period for a total treatment duration of 8 weeks. The treatment phase will be followed by a 1-week follow-up.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lisdexamfetamine dimesylate
Arm Type
Experimental
Arm Description
A central nervous system stimulant, specifically, a prodrug of dextro-amphetamine
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine dimesylate
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
50mg or 70mg oral capsules taken once-daily for to 2 months. The trial will begin with a 4-week titration phase, where patients will titrate up to a dose of 50mg/day or 70mg/day, followed by a 4-week maintenance phase. No dose changes will be permitted during the maintenance phase.
Primary Outcome Measure Information:
Title
Enrolment rate
Description
Enrolment rate will be defined as the total number of participants enrolled divided by the total enrolment period in months.
Time Frame
2 years
Title
Dropout rates
Description
Dropout rate will be defined as the number of patients whose participation was terminated prior to completion of the post-treatment assessment divided by the total number of participants enrolled.
Time Frame
2 years
Title
The applicability of eligibility criteria
Description
The applicability of eligibility criteria will be determined by the ratio of participants screened to participants enrolled.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of serious or other treatment-emergent adverse events (TEAEs)
Description
Subjects will be asked to report TEAEs to the research team and PI.
Time Frame
Up to 9 weeks
Title
Change from baseline in weight/body mass index
Description
Subjects will be weighed using a calibrated hospital scale while wearing a hospital gown and no footwear.
Time Frame
Up to 9 weeks
Title
Change from baseline in systolic/diastolic blood pressure (mmHg)
Description
Systolic and diastolic blood pressure will be collected by a study investigator at weekly/biweekly visits.
Time Frame
Up to 9 weeks
Title
Change from baseline in heart rate (bpm)
Description
Heart rate will be collected by a study investigator at weekly/biweekly visits.
Time Frame
Up to 9 weeks
Title
Incidence of abnormal adherence rates
Description
Adherence will be calculated as the number of pills not returned divided by the number of days since the last visit, multiplied by 100 to yield a percentage. Subjects with an adherence rate between 80% and 120% will be considered adherent to treatment.
Time Frame
2 months
Title
Incidence of abnormalities in blood analysis
Description
Most relevant concerns for patients with BN taking LDX include electrolyte abnormalities (potassium, sodium, chloride) and hypoglycemia
Time Frame
Up to 9 weeks
Title
Incidence of abnormalities in EKG
Description
Most relevant concerns for patients with BN taking LDX include prolonged QTc, hypertension, and tachycardia.
Time Frame
Up to 9 weeks
Title
Incidence of thoughts, ideations, and attempts of suicide, as measured by the Columbia-Suicide Severity Rating Scale (Since Last Visit Version)
Description
A clinician-observed measure designed to assess suicidal ideations and suicidal behaviours since the last visit in clinical trials. The scale consists of 4 sections. Section 1 regards suicidal ideation and consists of 5 "yes" or "no" questions. Section 2 regards the intensity of ideation and asks the patient to describe their most severe ideation. In regard to that ideation, the patient then indicates frequency, duration, controllability, deterrents, and reasons for ideation. Section 3 regards suicidal behaviour, and indicates if there has been an actual attempt, interrupted attempt, aborted attempt, or preparatory acts/behaviour since the last visit. Additionally, there is a section to indicate if there was suicidal behaviour during the assessment or if there was a suicide since the last visit. Section 4 specifies information about actual attempts only (actual lethality/medical damage and potential lethality).
Time Frame
Up to 9 weeks
Title
Change from baseline in the number of binge eating episodes per week
Description
Subjects will record the number of binge eating episodes in a food diary, which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit.
Time Frame
Up to 9 weeks
Title
Change from baseline in the number of purging episodes per week
Description
Subjects will record the number of self-induced vomiting episodes in a diary which will be validated weekly by a clinician using structured questions from the Eating Disorder Examination Interview inquiring about symptom frequency since the previous study visit.
Time Frame
Up to 9 weeks
Title
Change from baseline in the number of binge eating and purging days per week
Description
Binge eating and purging days are defined as having one or more episodes of binge eating or purging in a day, respectively.
Time Frame
Up to 9 weeks
Title
Change from baseline in the Eating Disorder Examination Interview scores
Description
A clinician-administered scale that assesses the severity of 4 areas of eating disorder psychopathology over the past 4 weeks (28 days): Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed. A higher score indicates increased severity. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale (i.e., the mean of all subscale items). To obtain a global score, the four subscales scores are summed and the resulting total divided by the number of subscales (i.e., the mean of all items). The scale consists of 28 items.
Time Frame
Week 1, Post (End of week 8)
Title
Change from baseline in the Barratt Impulsiveness Scale scores
Description
This 30-item measure assesses the personality/behavioural construct of impulsiveness and is widely accepted as the primary self-report measure of impulsivity. Items are ranked on a 1-4 scale (1 being "rarely/never" and 4 being "almost always/always"). A total score can be calculated using all 30 items. A higher score indicates higher levels of impulsivity.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Change from baseline in Yale-Brown Obsessive Compulsive Scale modified for binge eating (Y-BOCS-BE)
Description
A 10-item, clinician-administered rating scale for measuring the severity of OCD symptoms as they relate to binge eating. A higher score indicates increased severity. An obsessional subtotal can be calculated by adding items 1-5. A compulsion subtotal can be calculated by adding items 6-10. A total score can be calculated by adding all items. This version will be further modified to assess both binge eating and purging behaviours.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Change from baseline in the three subscale scores of the Three-Factor Eating Questionnaire (TFEQ)
Description
A 51-item self-report scale that assesses three areas of eating behaviours: Cognitive restraint of eating, disinhibition, and hunger.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Change from baseline in Clinical Impairment Assessment (CIA) scale scores for measuring ED impairment
Description
A 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features over the past 28 days. Each item is ranked on a 0-3 scale (0 being "not at all" and 3 being "a lot").
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Percent of treatment responders (binge and purge response rate)
Description
Responders defined as ≥50% reduction in the number of binge and/ or purge episodes from baseline to the last two preceding weeks of treatment.
Time Frame
Through study completion, up to two years
Title
Percent of binge and purge remission (binge and purge remission rate)
Description
Cessation defined as 100% reduction in binge and/or purge episodes in the last 28 days of treatment.
Time Frame
Through study completion, up to two years
Title
Change in Clinical Global Impression - Severity Scale (CGI-S)
Description
A 7-point scale that requires the clinician to rate the severity of the patient's illness at time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Time Frame
Screening visit, Week 5, Post (End of week 8)
Title
Change in the Modified Two-Step Task parameters
Description
As measured by the Modified Two-Step Task. This task examines exploration/exploitation (choice consistency), as well as goal-directed (i.e., model-based) and habitual (i.e., model-free) control.
Time Frame
Week 1, Week 2, Week 5, Week 9 (1-week Follow-up)
Title
Change from baseline in the Coping Self-Efficacy Scale (CSES)
Description
A 26-item measure of one's confidence in performing coping behaviors when faced with life challenges.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Change from baseline in the Locus of Control of Behaviour (LCB)
Description
A 17-item measure of the extent to which subjects perceive responsibility for their behaviour.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Change from baseline in Motivation, Confidence, and Readiness for Behaviour Change Questions
Description
A 3-item measure that assesses the perceived value of changing binge eating, confidence in ability to change binge eating, and readiness to change binge eating.
Time Frame
Week 1, Week 5, Post (End of week 8)
Title
Qualitative Patient Experience Interview
Description
An exploratory interview which aims to collect qualitative information on each patient's experiences with the study medication (i.e., from the patient's perspective, how does the medication affect their eating disorder symptoms?).
Time Frame
Week 5, Week 9 (1-week Follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-55 years of age and signed consent
Diagnosis of moderate to extreme bulimia nervosa (4 or more episodes of compensatory behaviours per week).
A body mass index (BMI) between 22 and 30 (calculated as kilograms per meters squared).
Subject is consistently able to swallow a capsule
If female, not breast feeding and not of child bearing potential (the latter defined as last menstruation at least 24 months prior to baseline, has undergone tubal ligation, and undergone hysterectomy)
If female of childbearing potential, agree to use a reliable form of birth control and has a negative serum pregnancy test prior to medication initiation.
Exclusion Criteria:
A comorbid bipolar disorder, psychotic disorder, moderate-severe depression, and/or ADHD using the SCID-4.
Previous history of anorexia nervosa (e.g., due to the risk of problematic weight loss secondary to stimulant misuse).
Severly restrictive eating behaviours, defined as routinely (>2 days a week) eating less than 2 meals a day or at the investigator's discretion.
Clinically meaningful abnormalities in laboratory tests or electrocardiography results (most relevant concerns include electrolyte abnormalities, hypoglycemia, prolonged QTc, hypertension, and tachycardia).
Personal or family history of cardiovascular disease that could increase the vulnerability to the sympathomimetic effects of stimulants (e.g., structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, advanced arteriosclerosis, or coronary artery disease) or any current symptomatic cardiovascular disease, as determined by the PI, and/or in consultation with cardiologist (as needed).
Subject has moderate to severe hypertension (>140/90 mmHg).
Subject is receiving psychotherapy for the treatment of BN.
Subject is taking or has taken a psychostimulant within the past 3 months.
Subject is taking another psychotropic medication AND the dose has been changed 4 weeks prior to study medication initiation (e.g., baseline).
Subject is on an antipsychotic medication (due to opposing mechanism of action).
A suspected history of substance use disorder in the preceding 6 months or more distant (e.g., severe history of prior stimulant abuse) or a lifetime history of stimulant substance use disorder.
Subject is taking or has taken a monoamine oxidase inhibitor (MAOI) within the last 14 days or has a hypersensitivity to amphetamine products or other ingredients in LDX.
Subject is pregnant, plans to become pregnant, or is nursing.
Subject uses syrup of ipecac to self-induce vomiting.
Subject is considered a suicide risk.
Subject has a known allergy to amphetamines, or other non-medical ingredients in LDX, or is sensitive to, is allergic to, or has had a reaction to other stimulant medications.
Subject has been diagnosed with glaucoma (an eye disease).
Subject has been diagnosed with hyperthyroidism (an overactive thyroid gland).
Insufficient knowledge of English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Keshen, MD, FRCPC
Organizational Affiliation
Nova Scotia Health Authority/Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33534199
Citation
Keshen AR, Dixon L, Ali SI, Helson T, Nunes A, Milliken H, Gamberg S, Sadek J, Kaplan A, McElroy SL. A feasibility study evaluating lisdexamfetamine dimesylate for the treatment of adults with bulimia nervosa. Int J Eat Disord. 2021 May;54(5):872-878. doi: 10.1002/eat.23480. Epub 2021 Feb 3.
Results Reference
derived
Learn more about this trial
Lisdexamfetamine for Adults With Bulimia Nervosa
We'll reach out to this number within 24 hrs