OROS methylphenidate in the treatment of adults with ADHD: a 6-month, open-label, follow-up study.
BACKGROUND
This open-label trial followed a previously reported randomized, placebo-controlled trial of osmotic release oral system (OROS) methylphenidate (MPH) for the treatment of personality disorder (PD). Important findings from the double-blind phase are reexamined for long-term significance.


METHODS
Of 41 patients who completed the double-blind, placebo-controlled trial, 34 continued into this open-label phase. The Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) measured outcome. Patients were categorized using previously defined attention-deficit/hyperactivity disorder (ADHD) groups: ADHD alone, ADHD with emotional dysregulation (ADHD + ED), and ADHD plus emotional dysregulation plus oppositional symptoms (ADHD + ED + ODD); and 3 post hoc personality categories: patients with no PD (PD-negative), patients with 1 PD (PD-positive), and patients meeting criteria for 2 or more PDs (PD-plus).


RESULTS
Three WRAADDS-defined ADHD dimensions improved at similar levels (attention + disorganization, 61%; hyperactivity + impulsivity, 60%; and emotional dysregulation, 66%). All ADHD subgroups (ADHD alone, ADHD + ED, and ADHD + ED + ODD) improved. ADHD + ED + ODD patients had the highest level of social maladjustment at baseline and showed the most long-term improvement in this area. PD-plus patients were less likely to complete the study or show improvement. Sixty-five percent of treatment responders were on moderate doses (< or =54 mg/d) of OROS MPH. Vital signs and ECGs did not differ from baseline.


CONCLUSIONS
Eighteen (44%) patients completed the trial. All 3 ADHD dimensions showed similar, well-maintained improvement. Patients with several PDs responded poorly to treatment in this small trial.
Marchant
Barrie K
BK
Mood Disorders Clinic, Department of Psychiatry, University of Utah, Salt Lake City, UT, USA. fred.reimherr@hsc.utah.edu
Reimherr
Frederick W
FW
Halls
Corinne
C
Williams
Erika D
ED
Strong
Robert E
RE
D000342:Affective Symptoms / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D010552:Personality Assessment; D010554:Personality Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D012917:Social Adjustment; D014589:Utah
D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate