Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221468
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2005-09-15
Brief Title:
A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Status:
COMPLETED
Status Verified Date:
2007-03
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 research study is to obtain preliminary data regarding the effectiveness tolerability and safety of quetiapine therapy for adolescents who have a mood disorder and have at least one parent with bipolar disorder severe mood swings
Detailed Description:
Bipolar disorder is a common life-long progressive disease that typically begins in adolescence or early adulthood and is associated with significant morbidity and mortality Lish et al 1994 Family studies have shown that offspring of parents with bipolar disorder have a 30 chance of developing a mood disorder while children with both parents with a mood disorder with at least one with bipolar disorder have a 70 chance of developing a mood disorder Goodwin and Jamison 1990 Indeed children 18 years old have an even greater risk for developing bipolar disorder if they have a parent with the disorder reviewed in Lapalme et al 1997 DelBello and Geller 2002 Chang and Steiner 2003 Since the clinical manifestations of bipolar disorder often present early in life and may worsen with age it is imperative that this illness is recognized and treated as readily as possible Bipolar disorder may have a number of prodromal or early-onset presentations that do not include syndromal mania These prodromes may include cyclothymia dysthymia and subsyndromal manic depressive and mixed affective symptoms Chang et al 2000 reviewed in Lapalme et al 1997
There have been several investigations of divalproex for the treatment of mood symptoms in children at familial risk for bipolar disorder Chang et al 2002 Findling et al 2002 Chang et al found a significant reduction in mood symptoms and improvement in overall functioning following treatment with divalproex in 23 children who did not have bipolar I disorder but who were diagnosed with mood symptomssyndromes and who had a parent with bipolar disorder Chang et al 2002 Similarly Findling et al reported that children with mood symptoms and a multigenerational family history of bipolar disorder had a significant reduction in mood symptoms when treated with divalproex compared with placebo Findling et al 2002 To our knowledge there have been no studies evaluating the use of atypical antipsychotics for the treatment of children at familial risk for developing bipolar disorder who are diagnosed with mood disorders other than bipolar I disorder
Controlled investigations suggest that quetiapine is effective for the treatment of mania in adults and adolescents Adityanjee and Schulz 2003 Sachs et al 2002 DelBello et al 2002 Additionally quetiapine is particularly well-tolerated and safe in children and adolescents DelBello et al 2002 Findling 2003 Our group has reported that children at risk for bipolar disorder exhibit neurochemical abnormalities suggesting neuronal damage may occur prior to the onset or early in the course of a mood disorder Furthermore recent laboratory studies suggest that quetiapine may have neuroprotective properties Xu et al 2002 Therefore quetiapine is the ideal choice for the treatment of adolescents at familial risk for developing bipolar disorder who are presently exhibiting a mood disorder
There have been several investigations of divalproex for the treatment of mood symptoms in children at familial risk for bipolar disorder Chang et al 2002 Findling et al 2002 Chang et al found a significant reduction in mood symptoms and improvement in overall functioning following treatment with divalproex in 23 children who did not have bipolar I disorder but who were diagnosed with mood symptomssyndromes and who had a parent with bipolar disorder Chang et al 2002 Similarly Findling et al reported that children with mood symptoms and a multigenerational family history of bipolar disorder had a significant reduction in mood symptoms when treated with divalproex compared with placebo Findling et al 2002 To our knowledge there have been no studies evaluating the use of atypical antipsychotics for the treatment of children at familial risk for developing bipolar disorder who are diagnosed with mood disorders other than bipolar I disorder
Controlled investigations suggest that quetiapine is effective for the treatment of mania in adults and adolescents Adityanjee and Schulz 2003 Sachs et al 2002 DelBello et al 2002 Additionally quetiapine is particularly well-tolerated and safe in children and adolescents DelBello et al 2002 Findling 2003 Our group has reported that children at risk for bipolar disorder exhibit neurochemical abnormalities suggesting neuronal damage may occur prior to the onset or early in the course of a mood disorder Furthermore recent laboratory studies suggest that quetiapine may have neuroprotective properties Xu et al 2002 Therefore quetiapine is the ideal choice for the treatment of adolescents at familial risk for developing bipolar disorder who are presently exhibiting a mood disorder
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