NCT00482313

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

Completed Phase 3 Last updated 7 May 2010

What this trial tests

Phase 3 trial testing PR OROS Methylphenidate in Attention Deficit Hyperactivity Disorder in 30 participants. Completed in 1 April 2010.

Timeline

1 May 2007

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	Psychiatry Karolinska
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 May 2007
Primary completion	1 April 2010
Estimated completion	1 April 2010
Sites	1 location across Sweden

Drugs / interventions tested

• PR OROS Methylphenidate — full drug profile →
• Placebo

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Psychiatry Karolinska — full company profile →

Who can join

Adults 18 to 65, male only, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS.
  Time frame: Changes from baseline until endpoint at week 5
  ADHD-symptoms as measured by changes in the observer-rated CAARS from baseline until endpoint at week 5.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Methylphenidate treatment of adult male prison inmates with attention-deficit hyperactivity disorder: randomised double-blind placebo-controlled trial with open-label extension.
   Ginsberg Y, Lindefors N. · · 2012 · cited 63× · PMID 22075648 · DOI 10.1192/bjp.bp.111.092940
2. Long-term functional outcome in adult prison inmates with ADHD receiving OROS-methylphenidate.
   Ginsberg Y, Hirvikoski T, Grann M, Lindefors N. · · 2012 · cited 34× · PMID 22526730 · DOI 10.1007/s00406-012-0317-8
3. Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial.
   Ginsberg Y, Långström N, Larsson H, Lindefors N. · · 2015 · cited 17× · PMID 26284932 · DOI 10.1097/jcp.0000000000000395
4. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults.
   Boesen K, Paludan-Müller AS, Gøtzsche PC, Jørgensen KJ. · · 2022 · cited 12× · PMID 35201607 · DOI 10.1002/14651858.cd012857.pub2