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Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183612
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date January 8, 2014
Study Start Date  ICMJE May 2000
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
Olanzapine pharmacokinetics, safety, and effectiveness [ Time Frame: Measured over 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Influence of patient factors on olanzapine pharmacokinetics, safety and effectiveness; measured throughout 8 weeks
Change History Complete list of historical versions of study NCT00183612 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 Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Official Title  ICMJE Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
Brief Summary This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.
Detailed Description

Numerous advancements in mental health treatment have been made over the past decade. Unfortunately, these advancements have focused on adults and have not been fully extended to children and adolescents. With limited pediatric information on the pharmacokinetics and pharmacodynamics for drugs used to treat mental health problems, psychiatrists are prescribing drugs for children using data extrapolated from adults, which may lead to potentially life-threatening results. Olanzapine is widely prescribed to treat both children and adults. This study will determine the safety and effectiveness of olanzapine in children and adolescents with mental health disorders. The study will also compare the effects of gender, development, body composition, and metabolic genotype and phenotype on how olanzapine works.

All participants will receive olanzapine for up to 8 weeks. Blood collection will occur at each weekly study visit. On Visit 1, participants will receive their first dose of olanzapine and repeated blood collection will occur every hour for 24 hours. Blood collection will be used to determine the time it takes for olanzapine to be absorbed into the body, its duration of action, the extent of its distribution in the body, the manner in which it is excreted from the body, and its effects on organs of the body.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Psychotic Disorders
Intervention  ICMJE Drug: Olanzapine
Study Arms  ICMJE Not Provided
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 Terminated
Enrollment  ICMJE
 (submitted: September 13, 2005)
68
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of bipolar disorder with mania, mixed mania, or psychosis not otherwise specified
  • Meet certain laboratory result requirements
  • Have taken either lithium or valproate for 4 weeks or longer with no or only partial response
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • History of other serious unstable illness requiring medication
  • Diabetes mellitus
  • Abnormal physical examination and electrocardiogram (EKG) results
  • At risk for suicide or homicide (based on an assessment of suicidal history, intent or plan, mental state, mood, and substance use)
  • IQ less than 65
  • History of organic brain disease or seizure disorder
  • Recent exposure to an infectious disease, such as tuberculosis (TB) or meningitis
  • Current use of drugs that may interfere with the metabolism of olanzapine and unwilling to discontinue use during the study
  • Body mass index (BMI) less than the 5th OR greater than the 95th percentile for age and gender
  • History of smoking within 1 year prior to study entry
  • Pregnancy or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
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 NCT00183612
Other Study ID Numbers  ICMJE K08MH001765( U.S. NIH Grant/Contract )
K08MH001765 ( U.S. NIH Grant/Contract )
DSIR CT-M
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maurizio Fava, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Louise G. Cohen, PharmD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2014

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