Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181896
Status:
TERMINATED
Last Update Posted:
2011-07-15
First Post:
2005-09-13
Brief Title:
Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open-Label Study of Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar depression with adequate mood stabilization All youth will be closely monitored for treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents
Detailed Description:
While anti-manic agents can effectively control manic symptoms bipolar patients frequently continue to struggle with residual depressive symptomatology that can be associated with severe morbidity and suicidality Because antidepressants can activate manic symptoms in bipolar patients with depression the treatment of bipolar depression poses unique and challenging therapeutic dilemmas Thus the identification of appropriate safe and effective treatment strategies for the management of depression in bipolar youth is particularly taxing considering that pediatric mania is predominantly mixed with a strong depressive component A recent study in our program of bupropion SR in 30 adults with ADHD and Bipolar disorder treatment with bupropion SR was extremely well tolerated and was not associated with activation of manic symptoms Because bupropion has not been evaluated in the treatment of bipolar depression in youth there is a pressing need to evaluate its effectiveness and safety in the context of a treatment protocol aimed at carefully evaluating this issue
This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar depression with adequate mood stabilization All youth will be closely monitored for treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents
This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar depression with adequate mood stabilization All youth will be closely monitored for treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents
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