drugset / Trial / NCT00246220
A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder.
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of three doses of prolonged-release methylphenidate (a central nervous system (CNS) stimulant) in adult patients with attention deficit/hyperactivity disorder (ADHD).
Timeline
- Start
- 2005-03
- Primary completion
- —
- Completion
- 2006-11
Outcome
Met primary endpoint
paper significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01) PMID 18206857 ↗
Publications
- Results Medori R, Ramos-Quiroga JA, Casas M, Kooij JJ, Niemela A, Trott GE, Lee E, Buitelaar JK. A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 May 15;63(10):981-9. doi: 10.1016/j.biopsych.2007.11.008. Epub 2008 Jan 22.
- Buitelaar JK, Sobanski E, Stieglitz RD, Dejonckheere J, Waechter S, Schauble B. Predictors of placebo response in adults with attention-deficit/hyperactivity disorder: data from 2 randomized trials of osmotic-release oral system methylphenidate. J Clin Psychiatry. 2012 Aug;73(8):1097-102. doi: 10.4088/JCP.11m07528. Epub 2012 Jun 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 18 mg | Oral |
| Subject | Methylphenidate | Small molecule | 36 mg | Oral |
| Subject | Methylphenidate | Small molecule | 72 mg | Oral |