Lisdexamfetamine for Adults With Bulimia Nervosa

NCT ID: NCT03397446

Last Updated: 2020-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2020-05-19

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.

Conditions

Bulimia Nervosa

Keywords

Lisdexamfetamine Dimesylate; Lisdexamfetamine; Vyvanse; Eating Disorders; Mental Disorders; Central Nervous System Stimulants; Dextroamphetamine; LDX; Binge Eating; Purging; Bulimia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lisdexamfetamine dimesylate

A central nervous system stimulant, specifically, a prodrug of dextro-amphetamine

Group Type: EXPERIMENTAL

Lisdexamfetamine dimesylate

Intervention Type: DRUG

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.

Interventions

Lisdexamfetamine dimesylate

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.

Intervention Type: DRUG

Other Intervention Names

Vyvanse; LDX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Aaron Keshen

OTHER

Sponsor Role: lead

Responsible Party

Aaron Keshen

Psychiatrist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aaron Keshen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority/Dalhousie University

Locations

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37218020 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33534199 (View on PubMed)

Other Identifiers

LDXBN

Identifier Type: -

Identifier Source: org_study_id