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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Bupropion

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