Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181987
Status:
COMPLETED
Last Update Posted:
2013-10-22
First Post:
2005-09-13
Brief Title:
Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open-Label Study of Concerta in the Treatment of ADHD in Youth and Adults With Bipolar I Bipolar II and Bipolar Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2013-10
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 objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children ages 5 to 17 years old and adults ages 18 to 55 years old with Bipolar I Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate Concerta in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents
Detailed Description:
A leading source of difficulty in treating youth with Bipolar Disorder is its comorbidity with attention deficit hyperactivity disorder ADHD Systematic studies of children and adolescents show that rates of ADHD range from 60 to 90 in pediatric study participants with mania These findings could not be accounted for by the overlapping symptoms of distractibility talkativeness and physical hyperactivity suggesting that affected children may suffer from both disorders which was also consistent with findings of familial co-transmission of these two conditions Considering the well-documented morbidity and dysfunction associated with ADHD a comprehensive treatment approach to the management of the bipolar child with comorbid ADHD requires the development of appropriate therapeutic strategies for the treatment ADHD symptoms
The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children ages 5 to 17 years old and adults ages 18 to 55 years old with Bipolar I Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate Concerta in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents
The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children ages 5 to 17 years old and adults ages 18 to 55 years old with Bipolar I Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate Concerta in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents
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