Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305370
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2006-03-19
Brief Title:
Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Federal University of Rio Grande do Sul
Study Overview
Official Title:
Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD A Randomized Cross-Over Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-03
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:
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 associated with Methylphenidate MPHfor the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms The study design is a 4-week randomized double blind cross-over group trial Patients were randomized to aripiprazole MPH or aripiprazole placebo The main hypothesis is Aripiprazole MPH will significantly reduce ADHD scores compared to aripiprazole 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 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 associated with Methylphenidate MPH for the treatment of 20 children and adolescents age range 8 to 17 years-old with Bipolar Disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms The study design is a 4-week randomized double blind cross-over group trial Patients were randomized to aripiprazole MPH or aripiprazole placebo The hypotheses are 1 Aripiprazole MPH will significantly reduce ADHD scores compared to aripiprazole placebo 2 Patients receiving aripiprazole MPH will not deteriorate in maniac symptoms
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