Status:
TERMINATED
Lisdexamfetamine for Adults With Bulimia Nervosa
Lead Sponsor:
Aaron Keshen
Collaborating Sponsors:
Nova Scotia Health Authority
Conditions:
Bulimia Nervosa
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 thi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03397446
Start Date
June 21 2018
End Date
May 19 2020
Last Update
November 27 2020
Active Locations (1)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H2E2