Bipolar DisorderPhase 4NCT00181935
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
A Phase 4 study testing risperidone (Risperdal) and olanzapine (Zyprexa) in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- risperidone (Risperdal) and olanzapine (Zyprexa)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Jul 2004
- Phase
- Phase 4
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients, 4-6 years of age.
- Parent or 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.
- Patients and their legal representative must be considered reliable.
- Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document.
- Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
- Patients must have an initial score on the Y-MRS total score of at least 15.
- Patient must be able to participate in mandatory blood draws.
Who cannot join
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
- Leukopenia or history of leukopenia without a clear and resolved etiology.
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- Judged clinically to be at serious suicidal risk.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
- History of intolerance or non-responder to risperidone, or olanzapine as determined by the principal investigator.
- Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior to Visit 2.
- Current diagnosis of schizophrenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Open-Label Comparative Study of Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Spectrum Disorder
The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.
Read the detailed description
Risperidone and olanzapine are atypical neuroleptics marketed for the treatment of psychotic disorders in adults. These medicines are called atypical neuroleptics because of their unique pharmacological profile, which include both D2 and 5HT2 antagonistic effects. The combined dopaminergic and serotonergic activity seems to be associated not only with antipsychotic effects, but also with mood stabilizing, mood elevating and tardive dyskinesia. The anti-climactic effects of this class of drugs led to the recent FDA approval of olanzapine as monotherapy for adult bipolar disorder.
The study will consist of 8 week, open-label treatment period with random assignment to two determined treatment arms, risperidone or olanzapine. We plan to enroll 5 subjects for each arm. During the 8 weeks of treatment, patients will be seen at weekly intervals and receive study medication. At each week, measures of safety and efficacy will be obtained. Two teams of clinicians will see the patient at each visit. Team 1 will be the treating team, adjusting medication dosages and determining the safety of continuation in the study for the patient. Team 2 will be blind to the randomization status of the patient and will assess clinical improvement using the efficacy measures. For patients who have completed the 8-week acute phase without adverse event and have not responded to the medication they were assigned to will be allowed to then take part in additional 8-week trial with the other medication. At the end of the 8 weeks, patients who responded to their assigned treatment will be eligible to be enrolled and invited to participate in a separate10 month continuation study.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- risperidone (Risperdal), olanzapine (Zyprexa)
- Keywords
- bipolar disorder, preschoolers, risperdal, zyprexa
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone (Risperdal)Drug
olanzapine (Zyprexa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in symptoms measured by
Young Mania Rating Scale
Mania Symptom Checklist
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 startMar 2001
- Study completionJul 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181935
- Sponsor's protocol ID
- 2001-P-000422
- Status last verified
- May 2013
- First submitted
- 13 Sep 2005
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Comparative Study of Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00181935
- Acronym / sponsor ID
- 2001-P-000422
- Conditions
- Bipolar Disorder, Mania
- Keywords
- bipolar disorder, preschoolers, risperdal, zyprexa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- Jul 2004 (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.
The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.
Detailed description
Risperidone and olanzapine are atypical neuroleptics marketed for the treatment of psychotic disorders in adults. These medicines are called atypical neuroleptics because of their unique pharmacological profile, which include both D2 and 5HT2 antagonistic effects. The combined dopaminergic and serotonergic activity seems to be associated not only with antipsychotic effects, but also with mood stabilizing, mood elevating and tardive dyskinesia. The anti-climactic effects of this class of drugs led to the recent FDA approval of olanzapine as monotherapy for adult bipolar disorder.
The study will consist of 8 week, open-label treatment period with random assignment to two determined treatment arms, risperidone or olanzapine. We plan to enroll 5 subjects for each arm. During the 8 weeks of treatment, patients will be seen at weekly intervals and receive study medication. At each week, measures of safety and efficacy will be obtained. Two teams of clinicians will see the patient at each visit. Team 1 will be the treating team, adjusting medication dosages and determining the safety of continuation in the study for the patient. Team 2 will be blind to the randomization status of the patient and will assess clinical improvement using the efficacy measures. For patients who have completed the 8-week acute phase without adverse event and have not responded to the medication they were assigned to will be allowed to then take part in additional 8-week trial with the other medication. At the end of the 8 weeks, patients who responded to their assigned treatment will be eligible to be enrolled and invited to participate in a separate10 month continuation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female patients, 4-6 years of age.
- Parent or 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.
- Patients and their legal representative must be considered reliable.
- Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document.
- Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
Key exclusion criteria (11 listed)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease
- Uncorrected hypothyroidism or hyperthyroidism.
- History of severe allergies or multiple adverse drug reactions.
- Non-febrile seizures without a clear and resolved etiology.
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 |
|---|---|---|
| risperidone (Risperdal) | Drug | – |
| olanzapine (Zyprexa) | Drug | – |
Primary outcome
reduction in symptoms measured by
Young Mania Rating Scale
Mania Symptom Checklist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone (Risperdal) and olanzapine (Zyprexa) in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital at 1 site 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 7 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: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
reduction in symptoms measured by. The study lists 3 primary outcomes in all. 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 6 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.