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

Last updated: July 14, 2011
Sponsor: Massachusetts General Hospital
Overall Status: Terminated

Phase

4

Condition

Depression

Bipolar Disorder

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00181896
2004-P-001727
  • Ages 6-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females age 6 to 17 with a diagnosis of current depression with bipolardisorder based on clinical assessment and confirmed by structured diagnostic interviewplus an initial Hamilton rating scale score >17 and a Young Mania Rating Score of <
  • Children will only be allowed to participate in the trial if they have had moodstabilization on a steady dose of medication for at least 2 months. By moodstabilization we mean as determined by principle investigator, evaluator clinician,and as confirmed by KSADS.

  • Subject and parent must have a level of understanding sufficient to communicateintelligently with the investigator and study coordinator, and to cooperate with alltests and examinations required by the protocol.

  • Subjects and their legal representative must be considered reliable.

  • Each subject and his/her authorized legal representative must understand the nature ofthe study. The subject's authorized legal representative must sign an informed consentdocument and the subject must sign an informed assent document.

  • Subject must be able to participate in mandatory blood draws.

  • Subject must be able to swallow pills.

Exclusion

Exclusion Criteria: Subjects with chronic medical illness, DSM-IV substance dependence within the past month,pregnant or nursing female subjects will be excluded from this study.

  • Investigator and his/her immediate family; defined as the investigator's spouse,parent, child, grandparent, or grandchild.

  • Serious, unstable illness including hepatic, renal, gastroenterological, respiratory,cardiovascular, endocrine, neurologic, immunologic, or hematologic disease.

  • History of severe allergies or multiple adverse drug reactions.

  • Non-febrile seizures without a clear and resolved etiology.

  • Leukopenia or history of leukopenia without a clear and resolved etiology.

  • Judged clinically to be at serious suicidal risk.

  • Acute Psychosis

  • Any other concomitant medication with primarily central nervous system activity otherthan specified in Concomitant Medication portion of the protocol.

  • History of intolerance or non-response to bupropion.

  • Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior toinitiation of study.

  • Current diagnosis of schizophrenia.

  • History of head trauma

  • CNS tumor

  • Diabetic treated with oral hypoglycemics or insulin

  • Current or prior diagnosis of bulimia or anorexia

Study Design

Total Participants: 1
Study Start date:
January 01, 2005
Estimated Completion Date:

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Cambridge, Massachusetts 02138
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.