NCT00181870

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

2.1 years

First QC Date

September 13, 2005

Last Update Submit

June 18, 2010

Conditions

Bipolar DisorderMania

Keywords

bipolar disorderchildrenmaniaEquetro

Outcome Measures

Primary Outcomes (1)

  • symptom reduction measured by YMRS

    8 weeks

Interventions

carbamazepine ER (Equetro)DRUG

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female subjects, 6-12 years of age.
  • Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version)(Kaufman, Birmaher et al. 1997). Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
  • Subjects and their legal representative 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.
  • Subjects must have an initial score on the Y-MRS total score of at least 20.
  • Subject must be able to participate in mandatory blood draws.
  • Subject must be able to swallow pills.
  • For concomitant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the ADHD therapy will not change throughout the duration of the study. Strattera will not be allowed.

You may not qualify if:

  • 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 (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • Uncorrected hypothyroidism or hyperthyroidism.
  • History of sensitivity to carbamazepine or known sensitivity to any of the tricyclic compounds such as amitriptyline, desipramine, imipramine, protriptyline and nortriptyline. Severe allergies or multiple adverse drug reactions.
  • Non-febrile seizures without a clear and resolved etiology.
  • History of previous bone marrow depression
  • DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
  • Judged clinically to be at serious suicidal risk.
  • Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
  • A non-responder or a history of intolerance to carbamazepine on an adequate trial (2 months or more at an adequate dose) as determined by the clinician.
  • Current diagnosis of schizophrenia.
  • Pregnant or nursing females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Janet Wozniak, 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

July 1, 2005

Primary Completion

August 1, 2007

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)