Trials / Active Not Recruiting
Active Not RecruitingNCT05416125
Vyvanse in Children Aged 6 to 12 Years
Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lisdexamfetamine Dimesylate | Vyvanse treatment |
| BEHAVIORAL | Lifestyle therapy | Lifestyle treatment |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2026-07-31
- Completion
- 2027-07-31
- First posted
- 2022-06-13
- Last updated
- 2026-01-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05416125. Inclusion in this directory is not an endorsement.