Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482313
Status:
COMPLETED
Last Update Posted:
2010-05-10
First Post:
2007-06-04
Brief Title:
Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder ADHD
Sponsor:
Psychiatry Karolinska
Organization:
Psychiatry Karolinska
Study Overview
Official Title:
A Single Centre Randomised Double-Blind Placebo-Controlled Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension in Swedish Male Prison Inmates With ADHD
Status:
COMPLETED
Status Verified Date:
2009-08
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:
The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD
Detailed Description:
The purpose of this study is to evaluate the efficacy of Prolonged Release PR OROS methylphenidate in fixed dosage as compared to placebo and the effectiveness of flexible dosage Prolonged Release PR OROS methylphenidate in Swedish adult male prison inmates with attention-deficit hyperactivity disorder ADHD An initial randomised double-blind placebo-controlled parallel group trial for 5 weeks is followed by an open-label extension for maximum 47 weeks comprising altogether 52 weeks of treatment A follow-up is carried out 12 and 36 months post-study respectively
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