At a glance
ClinicalIndex Comparison Record- ✓Age 4–6 years
- ✓DSM-IV diagnosis of bipolar I, bipolar II, or bipolar spectrum disorder with current manic, hypomanic, or mixed symptoms
- ✓Young Mania Rating Scale (Y-MRS) total score ≥20
- ✓Able to participate in mandatory blood draws
- ✕Serious, unstable medical illness (hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic)
- ✕Uncorrected hypothyroidism or hyperthyroidism
- ✕History of severe allergies or multiple adverse drug reactions
- ✕Non-febrile seizures without clear, resolved etiology
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
In Brief
A Phase 4 clinical trial evaluating quetiapine for Bipolar Disorder and Mania. Completed, enrolled 30 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
2.5 - 5.0mg/kg PO BID quetiapine