Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Massachusetts General Hospital |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181883 |
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.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder Mania |
Drug: quetiapine (Seroquel) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meghan Kotarski, BS | 617 503-1051 | mkotarski@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Cambridge, Massachusetts, United States, 02138 | |
Contact: Meghan Dougherty, BS 617-503-1051 mdougherty2@partners.org | |
Contact: Megan Aleardi, BA 617 503-1405 maleardi@partners.org | |
Principal Investigator: Joseph Biederman, MD |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
Study ID Numbers: | 2004-P-001509 |
Study First Received: | September 13, 2005 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00181883 |
Health Authority: | United States: Institutional Review Board |
children bipolar disorder quetiapine preschoolers |
Quetiapine Affective Disorders, Psychotic Mental Disorders |
Bipolar Disorder Mood Disorders Psychotic Disorders |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |