Treatment of Major Depressive Disorder Using Botulinum Toxin A: A 24-Week Randomized, Double-Blind, Placebo-Controlled Study

摘要: OBJECTIVE To determine whether a single treatment of botulinum toxin A in the forehead (glabellar) region can improve symptoms depression patients with major depressive disorder (MDD), as defined by DSM-IV criteria. METHOD Thirty participants were randomly assigned to receive either placebo or (BTA; onabotulinumtoxinA) injections forehead. Female received 29 units; male 39 units. At week 12, groups crossed over. Participants evaluated at weeks 0, 3, 6, 15, 18, and 24 for improvement MDD using Patient Health Care Questionnaire-9, Beck Depression Inventory (BDI), 21-Item Hamilton Rating Scale (HDRS-21) objective measurement scales. The primary outcome was rate HDRS-21 response, ≥ 50% score reduction from baseline. study occurred July 2011 November 2012. RESULTS Patients who BTA 0 (BTA-first group) 12 (BTA-second had statistically significant compared placebo. Improvement continued over group that first even though cosmetic effects wore off 16 weeks. response rates 55% (6/11) BTA-first group, 24% (4/17) BTA-second 0% (0/19) (P < .0001). remission (score ≤ 7) 18% (2/11), (3/17), (0/19), respectively = .057). scores dropped -46% -35% -second versus -2% BDI (≥ baseline) 45% (5/11) 33% (6/18) 5% (1/19) .0067). 9) 27% (3/11), (6/18), (1/19), .09). -42% -15% CONCLUSIONS Botulinum injection glabellar associated may be safe sustainable intervention MDD. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01392963.