Drug used to treat narcolepsy and excessive sleepiness shows promise in pilot trial of patients with depressive symptoms associated with bipolar disorder
Modafinil, which is used to treat excessive sleepiness
associated with conditions such as narcolepsy and obstructive sleep apnea, has
shown promise in a preliminary trial of patients with depressive symptoms associated
with bipolar disorder, according to an article in the August issue of the American
Journal of Psychiatry.
In the preliminary study of 85 patients with bipolar
disorder, 44 percent of modafinil participants (dose 100-200 mg daily) reported
improvement in symptoms over the course of the six-week trial compared with percent
of patients randomized to placebo. Almost 40 percent (39 percent) reported that
symptoms were in remission at the end of the six-week trial. In contrast, 23 percent
of placebo patients reported improvement in symptoms during the study, with 18
percent reporting remission at the end of the study.
Mark Frye, MD, Director of the Mayo Clinic Mood Disorders
Clinic and Research Program, led the study, in 2005, when he was with the University
of California Los Angeles (UCLA). The authors had hypothesized that the drug might
also work against the excessive daytime sleepiness commonly associated with the
depressive phase of bipolar disorder.
“There are very few treatments for the depressive phase
of bipolar disorder and as a result there is an urgent need to evaluate potential
new therapeutics,” said Frye. “Mood stabilizers in general are better at treating
mania than depression, but the depressive phase of the illness is far more common.
We really need continued research in this area.”
“This is a placebo-controlled study with real world community
impact,” Frye said. The randomized, double-blind, placebo-controlled trial was
conducted at five sites (the University of California, Los Angeles; University
of Texas Southwestern; University of Cincinnati; and University of Munich and
the University of Freiburg in Germany) in the USA and Germany.
Modafinil was not associated with any greater risk of
mood swings associated with bipolar disorder.
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