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Bulimia NervosaPhase 2NCT03397446

Lisdexamfetamine for Adults With Bulimia Nervosa

A Phase 2 study testing Lisdexamfetamine dimesylate in people with Bulimia Nervosa, run by Aaron Keshen at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Bulimia Nervosa
What is being tested?
Lisdexamfetamine dimesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteCanada
Study dates
21 Jun 2018to 19 May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H2E2

Other trials in Canada

About this study

Official title: A Feasibility Study to Evaluate Lisdexamfetamine Dimesylate (Vyvanse) in Adults With Bulimia Nervosa

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.

Conditions
Bulimia Nervosa
Being tested
Lisdexamfetamine dimesylate
Keywords
Lisdexamfetamine Dimesylate, Lisdexamfetamine, Vyvanse, Eating Disorders, Mental Disorders, Central Nervous System Stimulants, Dextroamphetamine, LDX, Binge Eating, Purging, Bulimia Nervosa
Medical subject headings
Bulimia Nervosa, Feeding and Eating Disorders, Mental Disorders, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lisdexamfetamine dimesylateDrug

    Also called Vyvanse, LDX

    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.

Study groups in NCT03397446
Study groupRoleWhat they receive
Lisdexamfetamine dimesylateExperimentalA central nervous system stimulant, specifically, a prodrug of dextro-amphetamine
Receives: Drug: Lisdexamfetamine dimesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrolment rate

    Enrolment rate will be defined as the total number of participants enrolled divided by the total enrolment period in months.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. The applicability of eligibility criteria

    The applicability of eligibility criteria will be determined by the ratio of participants screened to participants enrolled.

    Measured: 2 years

Secondary outcomes (24)
  1. Incidence of serious or other treatment-emergent adverse events (TEAEs)

    Subjects will be asked to report TEAEs to the research team and PI.

    Measured: Up to 9 weeks

  2. 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.

    Measured: Up to 9 weeks

  3. 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.

    Measured: Up to 9 weeks

  4. Change from baseline in heart rate (bpm)

    Heart rate will be collected by a study investigator at weekly/biweekly visits.

    Measured: Up to 9 weeks

  5. 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.

    Measured: 2 months

  6. Incidence of abnormalities in blood analysis

    Most relevant concerns for patients with BN taking LDX include electrolyte abnormalities (potassium, sodium, chloride) and hypoglycemia

    Measured: Up to 9 weeks

  7. Incidence of abnormalities in EKG

    Most relevant concerns for patients with BN taking LDX include prolonged QTc, hypertension, and tachycardia.

    Measured: Up to 9 weeks

  8. 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).

    Measured: Up to 9 weeks

  9. 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.

    Measured: Up to 9 weeks

  10. 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.

    Measured: Up to 9 weeks

  11. 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.

    Measured: Up to 9 weeks

  12. 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.

    Measured: Week 1, Post (End of week 8)

  13. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  14. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  15. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  16. 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").

    Measured: Week 1, Week 5, Post (End of week 8)

  17. 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.

    Measured: Through study completion, up to two years

  18. 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.

    Measured: Through study completion, up to two years

  19. 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.

    Measured: Screening visit, Week 5, Post (End of week 8)

  20. 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.

    Measured: Week 1, Week 2, Week 5, Week 9 (1-week Follow-up)

  21. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  22. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  23. 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.

    Measured: Week 1, Week 5, Post (End of week 8)

  24. 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?).

    Measured: Week 5, Week 9 (1-week Follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start21 Jun 2018
  3. Primary completion19 May 2020
  4. Study completion19 May 2020

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397446
Sponsor's protocol ID
LDXBN
Status last verified
Nov 2020
First submitted
20 Dec 2017
Last updated
27 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dixon L, Bartel S, Brown V, Ali SI, Gamberg S, Murphy A, Brewer KL, McElroy SL, Kaplan A, Nunes A, Keshen AR. Secondary outcomes and qualitative findings of an open-label feasibility trial of lisdexamfetamine dimesylate for adults with bulimia nervosa. J Eat Disord. 2023 May 22;11(1):81. doi: 10.1186/s40337-023-00796-x.

    PubMed 37218020
  • 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.

    PubMed 33534199

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lisdexamfetamine dimesylate in people with Bulimia Nervosa, run by Aaron Keshen at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrolment rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397446, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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