Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00183612
Other study ID # K08MH001765
Secondary ID K08MH001765DSIR
Status Terminated
Phase N/A
First received September 13, 2005
Last updated January 7, 2014
Start date May 2000
Est. completion date April 2007

Study information

Verified date January 2014
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 68
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Olanzapine


Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts
United States Cambridge Health Alliance Medford Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Olanzapine pharmacokinetics, safety, and effectiveness Measured over 8 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2