Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181935
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2005-09-13
Brief Title:
Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None