Investigators reported results from a
small, randomized, double-blind trial of Modafinil as adjunct
therapy for fatigue and sleepiness accompanying major depression.
The two study groups were similar in age (average 45 years),
antidepressants in use (fluoxetine most common), and baseline
fatigue and sleepiness scores. After a 6-week trial, patients
on Modafinil showed a nonsignificant improvement in both symptoms
compared with those on placebo. Side effects in the Modafinil
group such as headache and nervousness were relatively uncommon.
Fatigue and sleepiness are common among patients with depression:
Dr. Doghrami cited prevalence statistics of 94% for fatigue
and up to 16% for hypersomnia and noted that both fatigue
and sleepiness are common even in complete responders to antidepressant
medication.
A few small, uncontrolled trials have examined adjunct therapy
with central nervous system stimulants with somewhat promising
results. Dr. Doghramji's group hypothesized that Modafinil,
a novel wake-promoting agent that has been used as therapy
for sleepiness in patients with narcolepsy and obstructive
sleep apnea and as therapy for fatigue in patients with multiple
sclerosis, might prove useful for patients with major depression
Activity of Modafinil compared with methylphenidate and
amphetamine
Study design and subject characteristics
TRIAL | ・ | Multicenter
(11), 6-week, double-blind, randomized, placebo-controlled,
parallel-group trial | ・ | Treatment
arms: Antidepressant plus Modafinil or Antidepressant
plus Placebo | ・ | Modafanil
titrated individually during first week and
once per week afterward as needed to dose
of 100, 200, 300, or maximum of 400 mg daily
| SUBJECTS | ・ |
Average age 45 years for both arms (Note:
Number of subjects in each arm was not given)
| ・ | Baseline
Hamilton Depression score =19 for both arms
(that is, subjects are partial responders
to antidepressant therapy) | ・ | Fluoxetine
most common antidepressant in both arms (14
subjects in Modafinil arm, 19 subjects in
placebo arm) | ・ |
Number of patients who withdrew due to side
effects was similar in both arms (4 subjects
in Modafinil arm, 6 subjects in placebo arm)
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Investigators found that there was statistically significant
improvement in fatigue and sleepiness for the Modafinil arm
compared with the placebo arm by 2 weeks. However, by the
end of the study (week 6), the differences were no longer
significant.
They concluded that Modafinil decreases fatigue and enhances
wakefulness among patients who are partial responders to antidepressant
therapy and that the drug is well tolerated.
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