Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048802
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2002-11-08
Brief Title:
Treatment and Outcome of Early Onset Bipolar Disorder
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Treatment and Outcome of Early Onset Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2014-01
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 study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizers alone in the maintenance treatment of adolescents with bipolar disorder
Detailed Description:
In children and adolescents bipolar disorder is often accompanied by symptoms such as hallucinations delusions or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the childs symptoms have remitted
Participants in this study are treated with lithium divalproex Depakote and one of the following atypical antipsychotic medications olanzapine Zyprexa risperidone Risperdal or quetiapine Seroquel for at least 24 weeks Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups The first group will continue to receive active mood stabilizer and atypical antipsychotic medication The second group will receive active mood stabilizer and placebo Participants are assessed weekly and followed for up to 18 months
Participants in this study are treated with lithium divalproex Depakote and one of the following atypical antipsychotic medications olanzapine Zyprexa risperidone Risperdal or quetiapine Seroquel for at least 24 weeks Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups The first group will continue to receive active mood stabilizer and atypical antipsychotic medication The second group will receive active mood stabilizer and placebo Participants are assessed weekly and followed for up to 18 months
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 |
|---|---|---|---|
| DSIR 84-CTM | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060845 |
| R01MH060845 | NIH | None | None |