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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Open-label prescription of Bupropion SR for 8 weeks.
Massachusetts General Hospital
Cambridge, Massachusetts, United States
reduction in depression symptoms assessed by
Time frame: baseline to 8 weeks
Children's Depression Rating Scale
Time frame: baseline to 8 weeks
Hamilton Depression Rating scale (HAM-D)
Time frame: baseline to 8 weeks
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