Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome
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Ages Eligible for Study:
10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female 10-18 years of age (both inclusive)
Genetically confirmed diagnosis of Prader-Willi Syndrome
Determined to be in nutritional phase 3 by clinical assessment based on Miller et al, 2011
Known genetic, hormonal, or chromosomal cause of cognitive impairment other than Prader-Willi Syndrome
Presence of currently active psychotic symptoms
Presence of any cardiovascular disorders, epilepsy, frequent migraines or severe asthma
Previous diagnosis of autism spectrum disorder by a qualified healthcare provider
Prior or concomitant use of a selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI), antipsychotic medication, wakefulness-promoting drug, or thyroid hormone unless dosage has been stable ≥6 months at time of screening