Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442039
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2007-02-27
Brief Title:
Lithium for the Treatment of Pediatric Mania
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long Term Safety Period Discontinuation Phase and Restabilization Period
Status:
COMPLETED
Status Verified Date:
2012-02
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 clinical trial is being performed under the Best Pharmaceuticals for Children Act signed into law in 2002 in order to improve pediatric labeling for off-patent drugs The purpose of this study is to examine the efficacy and safety of lithium in the treatment of pediatric patients with bipolar I disorder
Detailed Description:
This is a multiphase multicenter trial that will comprehensively examine lithium in the treatment of pediatric patients with bipolar I disorder In order to examine the treatment of bipolar disorder with lithium this study will include four phases of treatment The first phase the Pharmacokinetic Phase will include 8 weeks of Open Label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder Patients completing the Pharmacokinetic Phase may be eligible to continue in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment Subsequently patients meeting response criteria during the Long-Term Effectiveness Phase will be eligible to continue in the Discontinuation Phase During the Discontinuation Phase patients will be randomized to either placebo or lithium treatment for up to 28 weeks Finally those subjects who experience a mood relapse during the Discontinuation Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DUNS No 07-775-8407 | None | None | None |