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Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study.
J Clin Psychiatry 2014; 75(8):837-44JC

Abstract

OBJECTIVE

To determine whether a single treatment of botulinum toxin A in the forehead (glabellar) region can improve symptoms of depression in patients with major depressive disorder (MDD), as defined by DSM-IV criteria.

METHOD

Thirty participants were randomly assigned to receive either placebo or botulinum toxin A (BTA; onabotulinumtoxinA) injections in the forehead. Female participants received 29 units; male participants received 39 units. At week 12, the groups were crossed over. Participants were evaluated at weeks 0, 3, 6, 12, 15, 18, and 24 for improvement in MDD symptoms using the Patient Health Care Questionnaire-9, Beck Depression Inventory (BDI), and 21-Item Hamilton Depression Rating Scale (HDRS-21) objective measurement scales. The primary outcome was the rate of HDRS-21 response, defined as ≥ 50% score reduction from baseline. The study occurred from July 2011 to November 2012.

RESULTS

Patients who received BTA at week 0 (BTA-first group) and at week 12 (BTA-second group) had a statistically significant reduction in MDD symptoms as compared to placebo. Improvement in MDD continued over 24 weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at 12 to 16 weeks. HDRS-21 response rates were 55% (6/11) in the BTA-first group, 24% (4/17) in the BTA-second group, and 0% (0/19) in the placebo group (P < .0001). HDRS-21 remission rates (score ≤ 7) were 18% (2/11), 18% (3/17), and 0% (0/19), respectively (P = .057). HDRS-21 scores dropped -46% and -35% in the BTA-first and -second groups versus -2% in the placebo group (P < .0001). The BDI response rate (≥ 50% reduction from baseline) was 45% (5/11) in the BTA-first group, 33% (6/18) in the BTA-second group, and 5% (1/19) in the placebo group (P = .0067). BDI remission rates (score ≤ 9) were 27% (3/11), 33% (6/18), and 5% (1/19), respectively (P = .09). BDI scores dropped -42% and -35% in the BTA-first and -second groups versus -15% in the placebo group (P < .0001).

CONCLUSIONS

Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01392963.

Authors+Show Affiliations

1600 West 38th St, Ste 404, Austin, TX78731 michellemagidmd@gmail.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24910934

Citation

Magid, Michelle, et al. "Treatment of Major Depressive Disorder Using Botulinum Toxin A: a 24-week Randomized, Double-blind, Placebo-controlled Study." The Journal of Clinical Psychiatry, vol. 75, no. 8, 2014, pp. 837-44.
Magid M, Reichenberg JS, Poth PE, et al. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(8):837-44.
Magid, M., Reichenberg, J. S., Poth, P. E., Robertson, H. T., LaViolette, A. K., Kruger, T. H., & Wollmer, M. A. (2014). Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. The Journal of Clinical Psychiatry, 75(8), pp. 837-44. doi:10.4088/JCP.13m08845.
Magid M, et al. Treatment of Major Depressive Disorder Using Botulinum Toxin A: a 24-week Randomized, Double-blind, Placebo-controlled Study. J Clin Psychiatry. 2014;75(8):837-44. PubMed PMID: 24910934.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. AU - Magid,Michelle, AU - Reichenberg,Jason S, AU - Poth,Poppy E, AU - Robertson,Henry T, AU - LaViolette,Amanda K, AU - Kruger,Tillmann H C, AU - Wollmer,M Axel, PY - 2013/10/25/received PY - 2014/02/25/accepted PY - 2014/6/10/entrez PY - 2014/6/10/pubmed PY - 2014/11/5/medline SP - 837 EP - 44 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 75 IS - 8 N2 - OBJECTIVE: To determine whether a single treatment of botulinum toxin A in the forehead (glabellar) region can improve symptoms of depression in patients with major depressive disorder (MDD), as defined by DSM-IV criteria. METHOD: Thirty participants were randomly assigned to receive either placebo or botulinum toxin A (BTA; onabotulinumtoxinA) injections in the forehead. Female participants received 29 units; male participants received 39 units. At week 12, the groups were crossed over. Participants were evaluated at weeks 0, 3, 6, 12, 15, 18, and 24 for improvement in MDD symptoms using the Patient Health Care Questionnaire-9, Beck Depression Inventory (BDI), and 21-Item Hamilton Depression Rating Scale (HDRS-21) objective measurement scales. The primary outcome was the rate of HDRS-21 response, defined as ≥ 50% score reduction from baseline. The study occurred from July 2011 to November 2012. RESULTS: Patients who received BTA at week 0 (BTA-first group) and at week 12 (BTA-second group) had a statistically significant reduction in MDD symptoms as compared to placebo. Improvement in MDD continued over 24 weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at 12 to 16 weeks. HDRS-21 response rates were 55% (6/11) in the BTA-first group, 24% (4/17) in the BTA-second group, and 0% (0/19) in the placebo group (P < .0001). HDRS-21 remission rates (score ≤ 7) were 18% (2/11), 18% (3/17), and 0% (0/19), respectively (P = .057). HDRS-21 scores dropped -46% and -35% in the BTA-first and -second groups versus -2% in the placebo group (P < .0001). The BDI response rate (≥ 50% reduction from baseline) was 45% (5/11) in the BTA-first group, 33% (6/18) in the BTA-second group, and 5% (1/19) in the placebo group (P = .0067). BDI remission rates (score ≤ 9) were 27% (3/11), 33% (6/18), and 5% (1/19), respectively (P = .09). BDI scores dropped -42% and -35% in the BTA-first and -second groups versus -15% in the placebo group (P < .0001). CONCLUSIONS: Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01392963. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/24910934/Treatment_of_major_depressive_disorder_using_botulinum_toxin_A:_a_24_week_randomized_double_blind_placebo_controlled_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2014/v75n08/v75n0811.aspx DB - PRIME DP - Unbound Medicine ER -