Bipolar Disorder Clinical Trial
Official title:
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the
brain: serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 (IC50=30nM), and
adrenergic receptors.
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of
Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and
bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether
Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric
bipolar and bipolar spectrum disorder in this age group. The study results will be used to
generate hypotheses for a larger randomized controlled clinical trial with explicit
hypotheses and sufficient statistical power.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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