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Re: Provigil/Dex Study Details » Ritch

Posted by Rick on May 22, 2002, at 23:30:22

In reply to Re: Provigil/Dex Study Details » JonW, posted by Ritch on May 22, 2002, at 23:02:12

> > Hi all,
> >
> > In the study I've pasted below it says that both dextroamphetamine and modafinil were superior to placebo, but does anyone know more about this study? Were the two meds comparable or was one superior to another?
> >
> > --------------------------------------------------
> > Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults.
> >
> > Taylor FB, Russo J.
> >
> > Rainier Associates, Tacoma, Washington 98467, USA. taylor2@earthlink.net
> >
> > Our objective was to compare the efficacy of the new wake-promoting drug modafinil to that of dextroamphetamine for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. Twenty-two adults who met DSM-IV criteria for ADHD participated in a randomized, double-blind, placebo-controlled, three-phase crossover study comparing placebo, modafinil, and dextroamphetamine for the treatment of ADHD. The twice-daily study medications were titrated to doses of optimum efficacy over 4-7 days and then held constant during the rest of each 2-week treatment phase. Measures of improvement included the DSM-IV ADHD Behavior Checklist for Adults, the Controlled Oral Word Association Test (COWAT, using the letters C, F, and L version), Stroop, and Digit Span (Wechsler Adult Intelligence Scale version). For the 21 (96%) completers, the mean (+/- SD) optimum doses of modafinil and dextroamphetamine were 206.8 mg/day +/- 84.9 and 21.8 mg/day +/- 8.9, respectively. Scores on the DSM-IV ADHD Checklist (p < 0.001) were significantly improved over the placebo condition following treatment with both active medications. Performance on the COWAT (p < 0.05) reached trend levels of significance. Both medications were generally well tolerated. This preliminary study suggests that modafinil may be a viable alternative to conventional stimulants for the treatment of adults with ADHD.
> >
> > Publication Types:
> > Clinical Trial
> > Randomized Controlled Trial
> >
> > PMID: 11191692 [PubMed - indexed for MEDLINE]
> > --------------------------------------------------
>
>
> I think one would have to gain access to the complete study, not just the abstract. My question is--when was this study done? Sounds interesting. I learned something new: there are *tests* that have *names* for ADHD testing! The COWAT test sounds interesting. I need to find a sample of that one.
>
> Mitch

The study cited above is apparently over two years old. The Medline header is:

J Child Adolesc Psychopharmacol 2000 Winter;10(4):311-20

Take a look at the passage below, from

http://www.ncpamd.com/NewADD_Meds.htm

The last line indicates that modafinil was found no better than placebo for adult ADHD. Despite this, I know that anecdotal reports indicate it works quite well for some people. And if memory serves (no guarantees on that count!), Cephalon plans additional study for Provigil in adult ADHD.

"Modafinil (Provigil) has been approved for treatment of narcolepsy in adults. It is chemically unrelated to methylphenidate or amphetamine. When compared to methylphenidate and amphetamine, it seems less likely to cause irritability and jitteriness. It appears to act on the frontal cortex and is more selective in its area of action than the traditional stimulants. Cephalon will be doing studies to assess the efficacy of modafinil in children with ADHD. In studies of adults with ADHD, there was a promising study (Taylor and Russo) suggesting that it might be effective for adults with ADHD. However a larger study sponsored by Cephalon indicated that Modafinil was no more effective than placebo."

Rick


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