- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00181935
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Open-Label Comparative Study of Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Young Mania Rating Scale
|
reduction in symptoms measured by
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Mania Symptom Checklist
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Bipolar and Related Disorders
- Disease
- Bipolar Disorder
- Mania
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Olanzapine
- Risperidone
Other Study ID Numbers
- 2001-P-000422
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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