title: Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial.
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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01556971.
authors.affiliation: Chevy Chase Cosmetic Center, Chevy Chase, MD 20815, USA. Electronic address: finzieric8@gmail.com.
authors.forename: Eric
authors.initials: E
authors.lastname: Finzi
authors.affiliation: Capital Clinical Research Associates, Rockville, MD 20852, USA; Georgetown Medical School, Washington, DC 20057, USA.
authors.forename: Norman E
authors.initials: NE
authors.lastname: Rosenthal
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use*; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011569:Psychiatric Status Rating Scales; D018709:Statistics, Nonparametric
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: Antidepressant; Clinical trial; Corrugator; Depression; Double blind; OnabotulinumtoxinA