Phase 3
Completed N=279
A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
Source: ClinicalTrials.gov NCT00714688 ↗Enrolled (actual)
279
Serious AEs
2.5%
Results posted
Apr 2010
Primary outcomePrimary: Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) — 36.5; 35.6; 37.3; 26.1 units on a scale — p=0.136
Summary
The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS) |
36.5; 35.6; 37.3; 26.1; 23.0; 21.6 | 0.136 |
| SECONDARY Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment |
0.0; -1.0; -1.0 | 0.216 |
| SECONDARY Clinical Global Impression-Change (CGI-C) |
3.0; 2.5; 2.0 | 0.052 |
| SECONDARY Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score |
-8.5; -12.8; -12.6 | 0.023 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV
- Described chronic course of ADHD symptomatology from childhood to adulthood, with some symptoms present before age 7 years and continue to meet DSM-IV criteria at the time of assessment
- CAARS score of at least or equal to 24 as determined by investigator at screening visit
- Patient agrees to take only the supplied study drug as treatment for ADHD during the study
- Patient agrees not to initiate a new behavioral modification program during the study or if currently using a behavioral modification program agrees not to change this program during the study.
Exclusion Criteria
- Known to be a non-responder to methylphenidate, or patient has a child known to be a non-responder to methylphenidate
- Has been treated with any methylphenidate-containing medication within 1 month of screening visit
- Participation in and premature withdrawal from 42603ATT3002, CR002479 or 42603ATT3004, CR011068 study
- Known allergy or hypersensitivity to methylphenidate, or components of PR OROS methylphenidate
- Any clinically unstable psychiatric condition including, but not limited to the following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder, borderline personality disorder.
Data sourced from ClinicalTrials.gov (NCT00714688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.