NCT01392963

The Treatment of Depression With Botulinum Type A Toxin

The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seton Healthcare Family · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	botulinum toxin type A neurotoxin complex	29-40 U injection
DRUG	Placebo	29-40 U 0.9% NaCl injection

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-11-01
• Completion: 2013-06-01
• First posted: 2011-07-13
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study