Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221403
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2005-09-14
Brief Title:
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Status:
COMPLETED
Status Verified Date:
2020-09
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 primary aim of this proposal is to conduct a preliminary controlled trial of valproate and risperidone in children ages 3-7 yr with bipolar disorders A secondary aim is to carefully characterize these subjects using clinical rating scales and develop pilot data on a very young cohort of children with bipolar disorders that can be used to support an application to NIMH for a prospective longitudinal study that will provide important information about the course medication response neurobiology and outcome of these patients
Detailed Description:
It is now recognized that pediatric bipolar disorders are highly prevalent and that they seriously disrupt the lives of children and adolescents with studies showing poorer academic performance disturbed interpersonal relationships increased rates of substance abuse legal difficulties multiple hospitalizations and increased rates of both suicide attempts and completions Akiskal Downs et al 1985 Lewinsohn Klein et al 1995 Strober Schmidt-Lackner et al 1995 We are seeing an increasing number of very young children ages 3-7 years with either frank symptoms of BP I disorder Over 50 of these young patients have a first-degree relative with a bipolar disorder and all of these patients families are significantly impacted by their BP symptoms Many of these young BP patients have been treated with stimulants or antidepressants and few have been treated with mood stabilizing agents Therefore it is necessary to provide controlled studies of psychotropics in this younger bipolar population to provide clinical practice with an appropriate evidence-base
Several major questions exist about these very young bipolar patients
What is the response of these very young bipolar patients to mood stabilizers and or atypical antipsychotics
Will non-responders to mono-therapy with either valproate or risperidone respond to treatment with both agents
How can we best characterize these patients clinically
What is the long-term outcome of these patients
Will earlier treatment lead to better outcomes
The clinical use of mood stabilizers and atypical antipsychotic agents in children and adolescents with bipolar disorders has increased significantly over the past few years despite the fact that only limited research has suggested that these agents are effective in this population Common clinical practice is to have patients continue on medications for some time following remission although the length of continuation treatment varies and available guidelines are based on consensus not controlled trials The increased number of medications prescribed has led to concern about over prescribing of psychotropics in children and adolescents Zito Safer et al 2000 Zito Safer et al 2003 Therefore it is necessary to provide additional controlled studies of mood stabilizing agents in this younger bipolar population to guide clinical practice
There is an overwhelming need for controlled trials of the various mood stabilizers and atypical antipsychotics that are now available and being used in the community with these young bipolar patients Currently we have the most experience with valproate and risperidone in bipolar children ages 8 - 17 yr and based on clinical experience believe that these two agents are the safest and most likely to be efficacious in children ages 3-7 years These agents are widely used in the community and controlled data are desperately needed regarding the effectiveness of these agents in bipolar children ages 3-7 years There are no specific behavioral treatments or psychotherapies that have been shown to be efficacious for these patients
Power Analysis Provided by Dr Judy Bean
Since this is a preliminary study prior to a larger controlled trial the percent of responders receiving one of the drugs will be compared to the percent of responders in the placebo arm The children will be randomized to achieve 24 total children in each drug arm and 12 in the placebo arm This 221 randomization scheme was selected because the expectation is that the percent of responders in each of the drug arms will be greater than the percent in the placebo arm The expectation is that 60 of the children receiving risperidone will respond Frazier Meyer et al 1999 as compared to only 8 in the placebo group Geller Cooper et al 1998 Power was calculated for a one-sided test since if placebo does better no application will be made to NIH Using nQuery version 50 a chi-square test with a 005 significance level will have 96 power to detect the difference For valproate the percent of responders is expected to be 55Kowatch Suppes et al 2000 as compared to the 8 in the placebo arm Again using a chi-square test with a 05 significance level the power will be 86 with 24 in the valproate arm and 12 in the placebo arm This pilot study does not power to determine if the two drug arms are equivalent
Several major questions exist about these very young bipolar patients
What is the response of these very young bipolar patients to mood stabilizers and or atypical antipsychotics
Will non-responders to mono-therapy with either valproate or risperidone respond to treatment with both agents
How can we best characterize these patients clinically
What is the long-term outcome of these patients
Will earlier treatment lead to better outcomes
The clinical use of mood stabilizers and atypical antipsychotic agents in children and adolescents with bipolar disorders has increased significantly over the past few years despite the fact that only limited research has suggested that these agents are effective in this population Common clinical practice is to have patients continue on medications for some time following remission although the length of continuation treatment varies and available guidelines are based on consensus not controlled trials The increased number of medications prescribed has led to concern about over prescribing of psychotropics in children and adolescents Zito Safer et al 2000 Zito Safer et al 2003 Therefore it is necessary to provide additional controlled studies of mood stabilizing agents in this younger bipolar population to guide clinical practice
There is an overwhelming need for controlled trials of the various mood stabilizers and atypical antipsychotics that are now available and being used in the community with these young bipolar patients Currently we have the most experience with valproate and risperidone in bipolar children ages 8 - 17 yr and based on clinical experience believe that these two agents are the safest and most likely to be efficacious in children ages 3-7 years These agents are widely used in the community and controlled data are desperately needed regarding the effectiveness of these agents in bipolar children ages 3-7 years There are no specific behavioral treatments or psychotherapies that have been shown to be efficacious for these patients
Power Analysis Provided by Dr Judy Bean
Since this is a preliminary study prior to a larger controlled trial the percent of responders receiving one of the drugs will be compared to the percent of responders in the placebo arm The children will be randomized to achieve 24 total children in each drug arm and 12 in the placebo arm This 221 randomization scheme was selected because the expectation is that the percent of responders in each of the drug arms will be greater than the percent in the placebo arm The expectation is that 60 of the children receiving risperidone will respond Frazier Meyer et al 1999 as compared to only 8 in the placebo group Geller Cooper et al 1998 Power was calculated for a one-sided test since if placebo does better no application will be made to NIH Using nQuery version 50 a chi-square test with a 005 significance level will have 96 power to detect the difference For valproate the percent of responders is expected to be 55Kowatch Suppes et al 2000 as compared to the 8 in the placebo arm Again using a chi-square test with a 05 significance level the power will be 86 with 24 in the valproate arm and 12 in the placebo arm This pilot study does not power to determine if the two drug arms are equivalent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None