Phase
Condition
Obesity
Diabetes Prevention
Treatment
Lisdexamfetamine Dimesylate
Lifestyle therapy
Clinical Study ID
Ages 6-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children ages 6 to <12 years at study entry
Severe obesity defined as BMI >/= 1.2 times the 95th percentile at the screeningvisit
Prior failed attempt of lifestyle therapy per parent/guardian report
Written informed consent of parent/legal guardian and written assent of participant
Exclusion
Exclusion Criteria:
Contraindications to lisdexamfetamine, including current or recent (< 14 days) useof monoamine oxidase inhibitor and known hypersensitivity to amphetamine products
Family history of sudden death or ventricular arrhythmia in any first or seconddegree relative with any of the following: sudden or unexplained death includingsudden infant death syndrome, cardiomyopathy, heart transplant, familial arrhythmia (such as Wolff-Parkinson-White syndrome, long QT interval, or implantabledefibrillator).
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 bloodpressure (DBP) >/= 95th percentile (on 3 separate occasions) at the screening ORbaseline/randomization visits
Tachycardia defined heart rate (HR) >/= 120 bpm (on 3 separate occasions) at thescreening 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 lipidmedication(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 12months
Any history of suicide attempt
Columbia Suicide Severity Rating Scale (C-SSRS) with a score of Moderate or Hiogh atthe screening or baseline/randomization visits
Children's Depressive Inventory 2 (CDE-2_ score >/= 70 (based on parent or childreport) at the screening or baseline/randomization visits
Concomitant use of tricyclic antidepressants, selective serotonin re-uptakeinhibitors (SSRIs), serotonin and norepinephrine re-uptake inhibitors (SNRIs),lithium, fentanyl, tramadol, triptans, tryptophan, buspirone and St. John's wort atany time during the study
Refusal to use adequate contraception (double barrier method or stable hormonalcontraception plus single barrier method, tubal ligation, or abstinence) in girls ofchildbearing potential
Inability to swallow test capsule (participants will have two opportunities)
Study Design
Study Description
Connect with a study center
University of Minnesota
Minneapolis, Minnesota 55414
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55414
United StatesSite Not Available

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