Finding studies
Finding studies
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Lead
Janssen Research & Development, LLC
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
