Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116259
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2005-06-27
Brief Title:
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD A Randomized Double Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-08
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:
There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder This study aims to assess the efficacy of Aripiprazole a novel anti-psychotic drug for the treatment of children and adolescents with bipolar disorder comorbid with ADHD The study design is a 8-week randomized double blind parallel group trial Patients were randomized to either aripiprazole or placebo
The main hypotheses are
1 Aripiprazole will significantly reduce maniac scores compared to placebo
2 Aripiprazole will significantly reduce ADHD scores compared to placebo
The main hypotheses are
1 Aripiprazole will significantly reduce maniac scores compared to placebo
2 Aripiprazole will significantly reduce ADHD scores compared to placebo
Detailed Description:
Bipolar disorder BD is a chronic disorder that severely affects the normal development of children and adolescents The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse Bipolar disorder in children is also associated with high rates of comorbidity especially with Attention-Deficit Hyperactivity Disorder ADHD There is a scarcity of clinical trials assessing the effects of medications in children with BD Moreover the frequent presence of comorbid ADHD might determine lower response to treatment Aripiprazole is a novel anti-psychotic drug Its mechanism of action seems to be related to a stabilization of dopaminergic transmission acting as a partial agonist especially in dopaminergic D2 receptors It also has effects in 5-HT1a serotonergic receptors Thus it might have a promising effect in children and adolescents with comorbid BD and ADHD A retrospective chart review recently published suggests the efficacy of this drug in children with BD This study aims to assess the efficacy of Aripiprazole a novel anti-psychotic drug for the treatment of 50 children and adolescents age range 08 to 17 years-old with Bipolar Disorder comorbid with ADHD The study design is an 6-week randomized double blind parallel group trial Patients were randomized to either aripiprazole or placebo The hypotheses are 1 Aripiprazole will significantly reduce maniac scores compared to placebo 2Aripiprazole will significantly reduce ADHD scores compared to placebo 3 Aripiprazole will not be significantly associated to weight gain compared to placebo
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 |
|---|---|---|---|
| GPPG03-325a | None | None | None |