Phase
Condition
Depression
Bipolar Disorder
Mood Disorders
Treatment
N/AClinical Study ID
Ages 6-17 All Genders
Study Summary
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
Study Description
Connect with a study center
Massachusetts General Hospital
Cambridge, Massachusetts 02138
United StatesSite Not Available

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.