Using Vyvanse to help children aged 6 to 12 with obesity
Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
This study tests if giving the medication Vyvanse along with lifestyle changes can help children aged 6 to 12 who are dealing with severe obesity manage their weight better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05416125 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of lisdexamfetamine combined with lifestyle therapy in children aged 6 to 12 years who are struggling with severe obesity. A total of 40 participants will be randomly assigned to receive either the medication or a placebo alongside lifestyle interventions over a 24-week period. The study seeks to determine if this combination can help improve weight management in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 12 years with severe obesity who have previously struggled with lifestyle therapy.
Not a fit: Patients who have contraindications to lisdexamfetamine or significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for children with severe obesity, potentially leading to better weight management and overall health.
How similar studies have performed: While this approach is relatively novel, similar studies exploring medication-assisted weight management in children have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Claudia Fox, MD — University of Minnesota
- Study coordinator: Claudia Fox, MD
- Email: lusc0001@umn.edu
- Phone: (612) 626-6616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.