drugset / Trial / NCT03078270
A Study of the Efficacy of Botox in the Treatment of Social Anxiety Disorder
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this study is to see whether Botox is an effective treatment for social anxiety disorder (SAD). Participants will complete two short surveys on depression and anxiety symptoms, receive a one-time injection of Botox, and complete the depression and anxiety survey 4 weeks after injection and again at 8 weeks after injection.
Timeline
- Start
- 2017-02-01
- Primary completion
- 2017-09-12
- Completion
- 2017-09-12
Outcome
Outcome not reported
Stopped (Enrollment): “study terminated due to low recruitment”
Publications
- Background Reichenberg JS, Hauptman AJ, Robertson HT, Finzi E, Kruger TH, Wollmer MA, Magid M. Botulinum toxin for depression: Does patient appearance matter? J Am Acad Dermatol. 2016 Jan;74(1):171-173.e1. doi: 10.1016/j.jaad.2015.08.051. No abstract available.
- Background Finzi E, Wasserman E. Treatment of depression with botulinum toxin A: a case series. Dermatol Surg. 2006 May;32(5):645-9; discussion 649-50. doi: 10.1111/j.1524-4725.2006.32136.x.
- Background Finzi E, Rosenthal NE. Emotional proprioception: Treatment of depression with afferent facial feedback. J Psychiatr Res. 2016 Sep;80:93-96. doi: 10.1016/j.jpsychires.2016.06.009. Epub 2016 Jun 16.
- Background Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Aug;75(8):837-44. doi: 10.4088/JCP.13m08845.
- Background Wollmer MA, de Boer C, Kalak N, Beck J, Gotz T, Schmidt T, Hodzic M, Bayer U, Kollmann T, Kollewe K, Sonmez D, Duntsch K, Haug MD, Schedlowski M, Hatzinger M, Dressler D, Brand S, Holsboer-Trachsler E, Kruger TH. Facing depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res. 2012 May;46(5):574-81. doi: 10.1016/j.jpsychires.2012.01.027. Epub 2012 Feb 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 40 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | Intramuscular |