Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176202
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2005-09-09
Brief Title:
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Controlled Trial of Risperidone and Divalproex Sodium With MRI Assessment of Affected Circuitry in Pre and Post Treatment in Pediatric Bipolar
Status:
COMPLETED
Status Verified Date:
2015-11
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 study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treatingstabilizing pediatric bipolar disorder
Detailed Description:
Pediatric Bipolar Disorder PBD severely impairs a childs emotional development and is associated with alarming rates of suicide school failure aggression risk taking behaviors and substance abuse Geller et al 1998 2001 Carlson et al 1998 At present very little is known about the pathophysiology or optimal treatment of PBD The long range goals of this proposal are threefold to investigate a range of pharmacotherapeutic agents that are safe and efficacious for PBD to use fMRI techniques to examine abnormalities in brain function in this disorder as well as any change in brain function after treatment
In contrast to the adult literature we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample In one lithium was found to be moderately effective in PBD with comorbid substance abuse Geller et al 1998 In the other divalproex sodium lithium and carbamazepine produced a maximum of 50 symptom reduction Kowatch et al 2000 Subsequently Kafantaris et al 2001 observed a potentiation of lithiums antimanic effect when combined with risperidone Further a prospective open trial of olanzapine for PBD reported a 70 symptom reduction Frazier et al 2001 with a retention rate of 96 compared to only 7 with classic mood stabilizers Kowatch et al 2000
Thus parallelling adult studies Sachs et al 2000 novel antipsychotics are a promising treatment in this population Further up to 60 of acute PBD episodes present with psychotic features Geller et al in press Finally the time to full effect with mood stabilizers is often 4 weeks in children Kowatch et al 2000 Geller et al 1998 Kafantaris et al 2001 whereas antipsychotics usually have a more rapid response onset Pavuluri et al in press Given the potential efficacy of novel antipsychotics for PBD the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer
In contrast to the adult literature we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample In one lithium was found to be moderately effective in PBD with comorbid substance abuse Geller et al 1998 In the other divalproex sodium lithium and carbamazepine produced a maximum of 50 symptom reduction Kowatch et al 2000 Subsequently Kafantaris et al 2001 observed a potentiation of lithiums antimanic effect when combined with risperidone Further a prospective open trial of olanzapine for PBD reported a 70 symptom reduction Frazier et al 2001 with a retention rate of 96 compared to only 7 with classic mood stabilizers Kowatch et al 2000
Thus parallelling adult studies Sachs et al 2000 novel antipsychotics are a promising treatment in this population Further up to 60 of acute PBD episodes present with psychotic features Geller et al in press Finally the time to full effect with mood stabilizers is often 4 weeks in children Kowatch et al 2000 Geller et al 1998 Kafantaris et al 2001 whereas antipsychotics usually have a more rapid response onset Pavuluri et al in press Given the potential efficacy of novel antipsychotics for PBD the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer
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