Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Mania
Intervention: carbamazepine ER (Equetro) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Joseph Biederman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: symptom reduction measured by YMRS
Detailed description:
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
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female subjects, 6-12 years of age.
2. 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).
3. 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.
4. Subjects and their legal representative must be considered reliable.
5. 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.
6. Subjects must have an initial score on the Y-MRS total score of at least 20.
7. Subject must be able to participate in mandatory blood draws.
8. Subject must be able to swallow pills.
9. Subjects with comorbid ADHD, ODD, CD, anxiety and depressive disorders will be allowed
to participate in the study provided they do not meet for any of the exclusionary
criteria.
10. 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.
Exclusion Criteria:
1. Investigator and his/her immediate family; defined as the investigator's spouse,
parent, child, grandparent, or grandchild.
2. Serious, unstable illness including hepatic, renal, gastroenterological, respiratory,
cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
immunologic, or hematologic disease.
3. Uncorrected hypothyroidism or hyperthyroidism.
4. 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.
5. Non-febrile seizures without a clear and resolved etiology.
6. History of previous bone marrow depression
7. DSM-IV substance (except nicotine or caffeine) dependence within past 6 months.
8. Judged clinically to be at serious suicidal risk.
9. Any other concomitant medication with primarily central nervous system activity other
than specified in Concomitant Medication portion of the protocol.
10. 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.
11. Current diagnosis of schizophrenia.
12. Pregnant or nursing females.
Locations and Contacts
Massachusetts General Hospital, Cambridge, Massachusetts 02138, United States
Additional Information
Starting date: July 2005
Last updated: June 10, 2008
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