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

This study has been terminated.
(Study was terminated due to lack of recruitment)
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181896
First received: September 13, 2005
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Depression
Bipolar Disorder
Drug: bupropion SR
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar and Bipolar Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • reduction in depression symptoms assessed by [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating scale (HAM-D) [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: January 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bupropion SR
    Open-label prescription of Bupropion SR for 8 weeks.
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females age 6 to 17 with a diagnosis of current depression with bipolar disorder based on clinical assessment and confirmed by structured diagnostic interview plus an initial Hamilton rating scale score >17 and a Young Mania Rating Score of < 15.
  • Children will only be allowed to participate in the trial if they have had mood stabilization on a steady dose of medication for at least 2 months. By mood stabilization 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 communicate intelligently with the investigator and study coordinator, and to cooperate with all tests 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 of the study. The subject's authorized legal representative must sign an informed consent document 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 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 other than 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 to initiation 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181896

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181896     History of Changes
Other Study ID Numbers: 2004-P-001727
Study First Received: September 13, 2005
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
depression
bipolar disorder
children
bupropion SR

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014