Treatment of depression with onabotulinumtoxinA: A randomized, double-blind, placebo controlled trial
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Fig. 1
MADRS scores over time (mean ± standard error of the mean), in the OBA(33) and placebo(41) groups at 3 and 6 weeks versus baseline.
Supplemental Fig. 2
Location of injection sites for male patients with corresponding doses in OBA units. The 0.40 ml total injection volume (40 units) for males was divided into five injections: 0.10 ml (10 units) in the procerus muscle, 0.08 ml (8 units) in the medial part of the corrugator muscle, and 0.07 ml (7 units) in the middle part of the corrugator muscle.
Abstract
Converging lines of evidence suggest a role for facial expressions in the pathophysiology and treatment of mood disorders.
To determine the antidepressant effect of onabotulinumtoxinA (OBA) treatment of corrugator and procerus muscles in people with major depressive disorder, we conducted a double blind, randomized, placebo-controlled trial. In an outpatient clinical research center, eighty-five subjects with DSM-IV major depression were randomized to receive either OBA (29 units for females and 40 units for males) or saline injections into corrugator and procerus frown muscles (74 subjects were entered into the analysis). Subjects were rated at screening, and 3 and 6 weeks after OBA treatment. The primary outcome measure was the response rate, as defined by ≥ 50% decrease in score on the Montgomery–Asberg Depression Rating Scale (MADRS). Response rates at 6 weeks from the date of injection were 52% and 15% in the OBA and placebo groups, respectively (Chi-Square (1) = 11.2, p < 0.001, Fisher p < 0.001). The secondary outcome measure of remission rate (MADRS score of 10 or less) was 27% with OBA and 7% with placebo (Chi-square (1) = 5.1, p < 0.02, Fisher p < 0.03). Six weeks after a single treatment, MADRS scores of subjects were reduced on average by 47% in those given OBA, and by 21% in those given placebo (Mann–Whitney U, p < 0.0005).
In conclusion, a single treatment with OBA to the corrugator and procerus muscles appears to induce a significant and sustained antidepressant effect in patients with major depression.
Trial Registration
clinicaltrials.gov Identifier: NCT01556971.
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