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Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00181844
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Janet Wozniak, MD, Massachusetts General Hospital

September 13, 2005
September 16, 2005
July 27, 2011
April 6, 2012
April 6, 2012
January 2005
February 2008   (Final data collection date for primary outcome measure)
Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS) [ Time Frame: baseline to 12 weeks ]
Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
  • reduction of mania symptoms as assessed by
  • Young Mania Rating Scale
  • Mania Symptom Checklist based on DSM-IV
Complete list of historical versions of study NCT00181844 on ClinicalTrials.gov Archive Site
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Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.

Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression.

The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Mania
Drug: lamotrigine
Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
Other Name: Lamictal
Experimental: Lamotrigine
Intervention: Drug: lamotrigine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
20
April 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subjects, 6-17 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 confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version. 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 stimulant 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 stimulant therapy will not change throughout the duration of the study.

Exclusion Criteria:

  1. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  2. Subjects unable to swallow pills.
  3. Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  4. History of sensitivity to lamotrigine or known, severe allergies or multiple adverse drug reactions.
  5. History of previous bone marrow depression.
  6. History of serious rashes.
  7. DSM-IV substance (except nicotine or caffeine) dependence within past 3 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 lamotrigine in 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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00181844
2004-P-001419
Yes
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Janet Wozniak, MD, Massachusetts General Hospital
Massachusetts General Hospital
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Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP