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Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

NCT00181870 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2010-06-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

carbamazepine ER (Equetro)

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Janet Wozniak, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00181870 on ClinicalTrials.gov