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Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial.
J Psychiatr Res 2014; 52:1-6JP

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.

Authors+Show Affiliations

Chevy Chase Cosmetic Center, Chevy Chase, MD 20815, USA. Electronic address: finzieric8@gmail.com.Capital Clinical Research Associates, Rockville, MD 20852, USA; Georgetown Medical School, Washington, DC 20057, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24345483

Citation

Finzi, Eric, and Norman E. Rosenthal. "Treatment of Depression With onabotulinumtoxinA: a Randomized, Double-blind, Placebo Controlled Trial." Journal of Psychiatric Research, vol. 52, 2014, pp. 1-6.
Finzi E, Rosenthal NE. Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial. J Psychiatr Res. 2014;52:1-6.
Finzi, E., & Rosenthal, N. E. (2014). Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial. Journal of Psychiatric Research, 52, pp. 1-6. doi:10.1016/j.jpsychires.2013.11.006.
Finzi E, Rosenthal NE. Treatment of Depression With onabotulinumtoxinA: a Randomized, Double-blind, Placebo Controlled Trial. J Psychiatr Res. 2014;52:1-6. PubMed PMID: 24345483.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial. AU - Finzi,Eric, AU - Rosenthal,Norman E, Y1 - 2013/12/01/ PY - 2013/08/27/received PY - 2013/11/13/revised PY - 2013/11/20/accepted PY - 2013/12/19/entrez PY - 2013/12/19/pubmed PY - 2015/1/27/medline KW - Antidepressant KW - Clinical trial KW - Corrugator KW - Depression KW - Double blind KW - OnabotulinumtoxinA SP - 1 EP - 6 JF - Journal of psychiatric research JO - J Psychiatr Res VL - 52 N2 - UNLABELLED: 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. SN - 1879-1379 UR - https://www.unboundmedicine.com/medline/citation/24345483/Treatment_of_depression_with_onabotulinumtoxinA:_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3956(13)00356-7 DB - PRIME DP - Unbound Medicine ER -