Bupropion SR for Major Depression & Depression NOS in Children &

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00181896
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Terminated
Phase	Phase 4
Start date	January 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms