Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181883
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2005-09-13
Brief Title:
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Seroquel is a psychotropic agent that affects multiple neurotransmitter receptors in the brain serotonin 5HT1A and 5HT2 dopamine D1 and D2 histamine H1 IC5030nM 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None