Bipolar DisorderNCT00183612
Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
A study testing Olanzapine in people with Bipolar Disorder and Psychotic Disorders, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bipolar Disorder, Psychotic Disorders
- What is being tested?
- Olanzapine
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2000to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Cambridge Health Alliance
Medford, Massachusetts, 02155
About this study
Official title: Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.
Read the 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.
- Conditions
- Bipolar Disorder, Psychotic Disorders
- Being tested
- Olanzapine
- Keywords
- Child, Adolescent, Mental Health, Olanzapine, Pharmacokinetics, Pharmacology
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Olanzapine pharmacokinetics, safety, and effectiveness
Measured: Measured over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2000
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Maurizio Fava, MD, Massachusetts General Hospital
- Investigators
- Louise G. Cohen, PharmD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183612
- Sponsor's protocol ID
- K08MH001765
- Other IDs
- K08MH001765, DSIR CT-M
- Status last verified
- Jan 2014
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
- ClinicalTrials.gov ID
- NCT00183612
- Acronym / sponsor ID
- K08MH001765
- Conditions
- Bipolar Disorder, Psychotic Disorders
- Keywords
- Child, Adolescent, Mental Health, Olanzapine, Pharmacokinetics, Pharmacology
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 68 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2000
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine | Drug | – |
Primary outcome
Olanzapine pharmacokinetics, safety, and effectiveness
Time frame: Measured over 8 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise G. Cohen, PharmD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine in people with Bipolar Disorder and Psychotic Disorders, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olanzapine pharmacokinetics, safety, and effectiveness (time frame: Measured over 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.