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

  [ 68 votes ]   [ Discuss This Article ]
By Natelson BH, Cheu J, Hill N, Bergen M, Korn L, Denny T, Dahl K • • April 15, 1998

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.

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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