drugset / Trial / NCT01392963
The Treatment of Depression With Botulinum Type A Toxin
RandomizedCrossoverDouble-blindTreatment
Summary
A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.
Timeline
- Start
- 2011-07
- Primary completion
- 2012-11
- Completion
- 2013-06
Outcome
Met primary endpoint
registry MEAN Botox, Then Placebo: -12.7 (Standard Deviation 4) units on a scale NCT01392963 ↗
registry analysis (other test); Placebo, Then Botox vs Botox, Then Placebo; p = 0.001; Mixed Models Analysis NCT01392963 ↗
Publications
- Results 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.
- Crowley JS, Silverstein ML, Reghunathan M, Gosman AA. Glabellar Botulinum Toxin Injection Improves Depression Scores: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2022 Jul 1;150(1):211e-220e. doi: 10.1097/PRS.0000000000009240. Epub 2022 May 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 29 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 40 iu | — |