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Vyvanse in Children Aged 6 to 12 Years

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Enrolling
Early Phase 1

Conditions

Obesity, Childhood

Treatments

Behavioral: Lifestyle therapy
Drug: Lisdexamfetamine Dimesylate

Study type

Interventional

Funder types

Other

Identifiers

NCT05416125
PEDS-2022-30981

Details and patient eligibility

About

This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.

Full description

This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children ages 6 to <12 years at study entry
  • Severe obesity defined as BMI >/= 1.2 times the 95th percentile at the screening visit
  • Prior failed attempt of lifestyle therapy per parent/guardian report
  • Written informed consent of parent/legal guardian and written assent of participant

Exclusion criteria

  • Contraindications to lisdexamfetamine, including current or recent (< 14 days) use of monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
  • Family history of sudden death or ventricular arrhythmia in any first or second degree relative with any of the following: sudden or unexplained death including sudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantable defibrillator).
  • Any history of fainting or seizure from exercise, startle, or fright
  • Clinically significant congenital or structural heart disease or arrhythmia BMI <1.2 times the 95th percentile at the baseline/randomization visits
  • Hypertension defined as systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) >/= 95th percentile at the screening OR baseline/randomization visits
  • Tachycardia defined heart rate (HR) >/= 120 bpm at the screening OR baseline/randomization visits
  • Current or recent (< 3 months) use of psychostimulant or sympathomimetic amine
  • History of chemical dependency
  • Diabetes mellitus (type 1 or 2)
  • Current or recent (< 3 months) use of anti-obesity medication(s)
  • Previous bariatric surgery
  • Recent initiation or change in dose (< 3 months prior) of anti-hypertensive or lipid medication(s)
  • Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)
  • Aspartate transaminase (AST) or alanine transaminase (ALT) > 3x ULN
  • Fasting glucose >/= 126 mg/dL
  • History of mania, schizophrenia, bipolar disorder, or psychosis
  • Unstable depression or anxiety that has required hospitalization in the past 12 months
  • Any history of suicide attempt
  • Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh at the screening or baseline/randomization visits
  • Children's Depressive Inventory 2 (CDE-2_ score >/= 70 (based on parent or child report) at the screening or baseline/randomization visits
  • Concomitant use of tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs), lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort at any time during the study
  • Refusal to use adequate contraception (double barrier method or stable hormonal contraception plus single barrier method, tubal ligation, or abstinence) in girls of childbearing potential

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Lifestyle therapy plus placebo
Placebo Comparator group
Description:
Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.
Treatment:
Behavioral: Lifestyle therapy
Lifestyle therapy plus lisdexamfetamine
Active Comparator group
Description:
Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.
Treatment:
Drug: Lisdexamfetamine Dimesylate

Trial contacts and locations

1

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Central trial contact

Claudia Fox, MD

Data sourced from clinicaltrials.gov

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