Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181870
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2005-09-13
Brief Title:
Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open-Label Study of Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar I Bipolar II and Bipolar Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2010-06
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 open-label pilot study of up to 1200 mgday of carbamazepine ER Equetro in the treatment of children who meet DSM-IV criteria for Bipolar I Bipolar II or Bipolar Spectrum Disorder The main goal of this study is to begin to address the void of information on safety tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder
Detailed Description:
Initial clinical evidence suggests that carbamazepine CBZ may play a therapeutic role in the management of pediatric bipolar disorder A recent study found that nearly 50 of patients taking immediate-release CBZ had side effects while only 20 of patients had side-effects after switching to an extended release ER version of the drug despite high doses In addition with an ER formulation of CBZ there is a potential for decrease in peak-related side effects and improved efficacy with higher blood levels Thus an ER formulation of CBZ may improve effectiveness and adherence to treatment
The goal of this pilot study is to evaluate the safety and effectiveness of Equetro in the treatment of bipolar I bipolar II and bipolar spectrum disorder in children ages 6-12 over the course of 8-weeks We propose that during this exploratory study there will be sufficient safety tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder The results of this study will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power
The goal of this pilot study is to evaluate the safety and effectiveness of Equetro in the treatment of bipolar I bipolar II and bipolar spectrum disorder in children ages 6-12 over the course of 8-weeks We propose that during this exploratory study there will be sufficient safety tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder The results of this study 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