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

NCT00181896 | Terminated Phase 4 DMC

• 1 other identifier: 2004-P-001727
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Bipolar Disorder

Keywords

depression; bipolar disorder; children; bupropion SR

Outcome Measures

Primary Outcomes (3)

• reduction in depression symptoms assessed by

  baseline to 8 weeks

• Children's Depression Rating Scale

  baseline to 8 weeks

• Hamilton Depression Rating scale (HAM-D)

  baseline to 8 weeks

Interventions

bupropion SR DRUG

Open-label prescription of Bupropion SR for 8 weeks.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2005
• Primary Completion: February 1, 2007
• Last Updated: July 15, 2011

Record last verified: 2011-07

Locations

US (1)