|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
Shire Pharmaceutical Development |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181870 |
Purpose
This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The main goal of this study is to begin to address the void of information on safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Mania |
Drug: carbamazepine ER (Equetro) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Open-Label Study of Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder |
| Enrollment: | 33 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Initial clinical evidence suggests that carbamazepine (CBZ) may play a therapeutic role in the management of pediatric bipolar disorder. A recent study found that nearly 50% of patients taking immediate-release CBZ had side effects while only 20% of patients had side-effects after switching to an extended release (ER) version of the drug, despite high doses. In addition, with an ER formulation of CBZ there is a potential for decrease in peak-related side effects and improved efficacy with higher blood levels. Thus, an ER formulation of CBZ may improve effectiveness and adherence to treatment.
The goal of this pilot study is to evaluate the safety and effectiveness of Equetro in the treatment of bipolar I, bipolar II, and bipolar spectrum disorder in children ages 6-12 over the course of 8-weeks. We propose that during this exploratory study there will be sufficient safety, tolerability, and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder. The results of this study will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| Principal Investigator: | Janet Wozniak, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Janet Wozniak, MD ) |
| Study ID Numbers: | 2005-P-000763 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00181870 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
bipolar disorder children mania Equetro |
|
Tranquilizing Agents Disease Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes |
Carbamazepine Mental Disorders Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Mood Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |