Status:
TERMINATED
Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Depression
Bipolar Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
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 ...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00181896
Start Date
January 1 2005
Last Update
July 15 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138