Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar Disorder Mania | Drug: risperidone (Risperdal) Drug: olanzapine (Zyprexa) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment |
| 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 |
- reduction in symptoms measured by
- Young Mania Rating Scale
- Mania Symptom Checklist
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2001 |
| Study Completion Date: | July 2004 |
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.
Eligibility
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| Ages Eligible for Study: | 4 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181935
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181935 History of Changes |
| Other Study ID Numbers: |
2001-P-000422 |
| First Submitted: | September 13, 2005 |
| First Posted: | September 16, 2005 |
| Last Update Posted: | May 6, 2013 |
| Last Verified: | May 2013 |
Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
|
bipolar disorder preschoolers risperdal zyprexa |
Additional relevant MeSH terms:
|
Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders Risperidone Olanzapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |