RECRUITING

Vyvanse in Children Aged 6 to 12 Years

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

Quick Facts

Study Start:2023-12-20

Study Completion:2029-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05416125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Claudia Fox, MD

CONTACT

(612) 626-6616

lusc0001@umn.edu

Principal Investigator

Claudia Fox, MD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Claudia Fox, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2029-11-30

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2029-11-30

Terms related to this study

Keywords Provided by Researchers

Obesity

Additional Relevant MeSH Terms

Obesity, Childhood