Single-blind, placebo phase-in trial of 2 escalating doses of selegiline in the Chronic Fatigue Syndrome (CFS)

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AIM: To perform a clinical trial of selegiline in 25 patients

with chronic fatigue syndrome (CFS) where patients were told

they would receive placebo or active agent at different times

during the 6-week trial. We chose selegiline, a specific

monoamine oxidase (MAO) B receptor inhibitor, because a prior

trial of lowdose phenelzine, a nonspecific MAO inhibitor,

showed a small but significant therapeutic effect.

METHODS:

Questionnaires comprised of 19 tests of mood, fatigue,

functional status and symptom severity were collected at the

start and end of the trial as well as 2 weeks after its start.

The trial was done in three 2-week blocks: in the first, 2

placebo pills were given per day; in the next, one 5-mg tablet

of agent and one placebo were given per day, and in the last,

a 5-mg tablet of agent was given twice a day. The plan was to

compare the changes in the 19 tests during the placebo phase

to those found in the active treatment phase in 19 patients

completing the trial.

FINDINGS: Significant improvement in 3

variables- tension/anxiety, vigor and sexual relations-was

found. A significant pattern of improvement compared to

worsening was found for the 19 self- report vehicles during

active treatment as compared with placebo treatment. Evidence

for an antidepressant effect of the drug was not found.

CONCLUSIONS: Selegiline has a small but significant

therapeutic effect in CFS which appears independent of an

antidepressant effect.

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