Previous studies have shown that severe
tinnitus is associated with current major depression, and that
tricyclic antidepressant therapy reduces
tinnitus disability, at least compared to brief placebo treatment. We are completing a randomized clinical trial of
nortriptyline, stratified by presence or absence of current major depression, in 100 patients with severe chronic
tinnitus. Preliminary analysis of global outcome on the first 52 patients reveals that those receiving
nortriptyline were more likely to feel that their
drug had been helpful (74% vs. 36%, p less than 0.01), but were equally likely to report that their
tinnitus was improved (37% vs. 32%, NS). So far, neither audiometric nor self-report measures of
tinnitus have demonstrated statistically significant differences between active
drug and placebo. Simply administered visual rating scales, if externally-referenced, correlated better with global outcome than did the Iowa
Tinnitus Handicap Questionnaire. As expected,
nortriptyline was significantly superior to placebo with respect to reductions in the Hamilton Depression Scale, especially in depressed patients. Paradoxically, depressed patients reported more disability and loudness on all scales, but had lower 1 kHz
tinnitus intensity matches and dynamic ranges. Our preliminary conclusions are that: 1)
nortriptyline reduces depression in patients with severe
tinnitus, 2) placebo effects are very important in the treatment of
tinnitus, 3) depression may be associated with decreased tolerance for both internal and external sounds, and 4) it is still difficult to specify the appropriate measures of
tinnitus loudness and disability for use in therapeutic trials.