Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT00482313
• Study type: Interventional
• Source: Psychiatry Karolinska
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Completion date: April 2010