Trials / Completed
CompletedNCT00181883
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Not accepted
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 (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | quetiapine | 2.5 - 5.0mg/kg PO BID quetiapine |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2009-04-01
- Completion
- 2009-04-01
- First posted
- 2005-09-16
- Last updated
- 2012-04-06
- Results posted
- 2012-04-06
Source: ClinicalTrials.gov record NCT00181883. Inclusion in this directory is not an endorsement.