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OROS methylphenidate shows benefits in patients with ADHD who have comorbid mood, anxiety disorders, concomitant drug therapy in trial

Thursday, December 13 2007 | Comments
Evidence Grade 0 What's This?
The efficacy, safety, and tolerability profile of OROS methylphenidate in adults who have attention-deficit/hyperactivity disorder appears to extend to those who have comorbid depression or anxiety disorders, including those taking concomitant serotonergic uptake inhibitors (SRIs), new findings suggest.

The double-blind trial was conducted among 182 adults (aged 19 to 60 years) who had ADHD according to DSM-IV criteria and the Kiddie Schedule for Affective Disorders and Schizophrenia Epidemiologic Version. Among this group, 12 patients concomitantly used SRIs at baseline, 36 had a lifetime history of comorbid mood or anxiety disorder, and 41 had only ADHD.

The patients were randomized to receive OROS methylphenidate or placebo for 6 weeks. Daily doses began at 36 mg and could be titrated up to 1.3 mg/kg if patients did not experience adverse effects, did not demonstrate a score of 1 or 2 on the Clinical Global Impression-Improvement scale (CGI), or did not have a >30% reduction in the Adult ADHD Investigator System Report Scale (AISRS) score.

AISRS was the primary outcome measure of ADHD symptoms, while the 17-item Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) assessed depression and anxiety symptoms. The CGI evaluated overall ADHD severity.

Mean AISRS scores decreased significantly in all subjects who received OROS methylphenidate relative to those who received placebo (-14.5 vs -9.2; P=.0006).

Clinical response rates--as determined by CGI <=2 ("much" or "very much" improved), a 30% change in AISRS score from baseline, or the researchers' a priori definition of clinical response--were comparable in patients with only ADHD, those with a comorbid mood or anxiety disorders, and those taking SRIs.

Across these 3 patient groups, symptoms of depression or anxiety were not exacerbated with OROS methylphenidate. For example, HAM-A scores were normal for patients taking SRIs at baseline and those who had comorbid disorders (4.2 and 3.9, respectively) as were HAM-D scores (5.1 and 4.8, respectively).

Among the patients who received OROS methylphenidate, adverse effects were similar. In addition, average cardiovascular parameters did not clinically significantly change among all the groups. However, the patients with only ADHD demonstrated a small increase in PR interval, while those with the comorbid disorders or those taking SRIs exhibited a mild decrease in this parameter, yielding a statistically significant association for PR interval. (Biederman J, et al. Poster NR358.)

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