Viewing Study NCT00036582



Ignite Creation Date: 2024-05-05 @ 11:25 AM
Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00036582
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2002-05-10

Brief Title: Clozapine vs Placebo in Treatment-Refractory Bipolar Disorder in Children and Adolescents
Sponsor: National Institute of Mental Health NIMH
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Clozapine vs Placebo In Treatment-Refractory Bipolar Disorder In Children And Adolescents
Status: COMPLETED
Status Verified Date: 2004-02
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 purpose of this study is to determine the safety and effectiveness of clozapine in children and adolescents with treatment resistant bipolar disorder This study will also explore how the brain functions in early-onset bipolar disorder
Detailed Description: Bipolar disorder BPD in children and adolescents is a serious illness that carries a high risk for chronicity impairing comorbidities and completed suicide Treatment options are often limited by inefficacy or intolerable side effects Open trials in adult bipolar subjects and several case series in children and adolescents provide preliminary evidence that clozapine an atypical antipsychotic may be effective in treatment-resistant bipolar disorder The first specific aim of this study is to test the efficacy and safety of clozapine compared to placebo in a double-blind study of children and adolescents with treatment refractory BPD Other specific aims involve exploring the pathophysiology of early-onset BPD by 1 testing the hypotheses that compared to controls children with BPD have increased psychophysiological reactivity to emotional stimuli and decreased prepulse inhibition 2 obtaining samples of genetic material from affected probands and their parents for later analysis and 3 identifying anatomic changes in the brains of children with BPD using structural MRI

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
Secondary IDs
Secondary ID Type Domain Link
02-M-0198 None None None