Lisdexamfetamine for Adults With Bulimia Nervosa

NCT03397446 | Terminated Phase 2

• 1 other identifier: LDXBN
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Enrolment rate

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

  2 years

• 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.

  2 years

• The applicability of eligibility criteria

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

  2 years

Secondary Outcomes (24)

• Incidence of serious or other treatment-emergent adverse events (TEAEs)

  Up to 9 weeks

• Change from baseline in weight/body mass index

  Up to 9 weeks

• Change from baseline in systolic/diastolic blood pressure (mmHg)

  Up to 9 weeks

• Change from baseline in heart rate (bpm)

  Up to 9 weeks

• Incidence of abnormal adherence rates

  2 months

Study Arms (1)

Lisdexamfetamine dimesylate

EXPERIMENTAL

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

Drug: Lisdexamfetamine dimesylate

Interventions

Lisdexamfetamine dimesylate 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.

Also known as: Vyvanse, LDX

Lisdexamfetamine dimesylate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aaron Keshen: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 37218020 DERIVED

• 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.

  PMID: 33534199 DERIVED

MeSH Terms

Conditions

Bulimia Nervosa; Feeding and Eating Disorders; Mental Disorders; Bulimia

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Aaron Keshen, MD, FRCPC

  Nova Scotia Health Authority/Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 12, 2018
• Study Start: June 21, 2018
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)