Vyvanse in Children Aged 6 to 12 Years

Launched by UNIVERSITY OF MINNESOTA · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called lisdexamfetamine, combined with lifestyle changes, on children aged 6 to 12 who are struggling with severe obesity. The trial aims to see if this treatment helps these children maintain a healthier weight compared to a group that will receive lifestyle therapy plus a placebo (a pill that looks like the medication but has no active ingredients). The researchers are currently looking for participants who have had difficulty with weight management and have previously tried lifestyle changes without success.

To participate, children must be between 6 and 12 years old and have a body mass index (BMI) that indicates severe obesity. They also need written permission from a parent or guardian to join the study. However, some children may not be eligible if they have certain health conditions, such as heart problems or recent use of specific medications. If chosen for the study, participants will receive regular check-ins and support throughout the program. This trial is an opportunity to help children find effective ways to manage their weight and improve their overall health.

Gender

ALL

Eligibility criteria

• 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