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Trial record 39 of 216 for:    Lamotrigine

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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE July 27, 2011
Results First Posted Date  ICMJE April 6, 2012
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE January 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • reduction of mania symptoms as assessed by
  • Young Mania Rating Scale
  • Mania Symptom Checklist based on DSM-IV
Change History Complete list of historical versions of study NCT00181844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Mania
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Lamotrigine
Intervention: Drug: lamotrigine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2012)
51
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00181844
Other Study ID Numbers  ICMJE 2004-P-001419
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janet Wozniak, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet Wozniak, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2012

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