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

Primary Purpose

Depression, Bipolar Disorder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion SR
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, bipolar disorder, children, bupropion SR

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

reduction in depression symptoms assessed by
Children's Depression Rating Scale
Hamilton Depression Rating scale (HAM-D)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
July 14, 2011
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00181896
Brief Title
Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder
Official Title
Open-Label Study of Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to lack of recruitment
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Disorder
Keywords
depression, bipolar disorder, children, bupropion SR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupropion SR
Intervention Description
Open-label prescription of Bupropion SR for 8 weeks.
Primary Outcome Measure Information:
Title
reduction in depression symptoms assessed by
Time Frame
baseline to 8 weeks
Title
Children's Depression Rating Scale
Time Frame
baseline to 8 weeks
Title
Hamilton Depression Rating scale (HAM-D)
Time Frame
baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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

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