NCT03833063

Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.

Detailed description

Feedback from facial expressions is known to influence emotional experience. Treatment of muscles involved in facial expression of sadness, anger or anxiety with botulinumtoxin showed a quick, strong and sustained improvement in the symptoms of depression. As considerable proportion of patients do not sufficiently respond to existing treatment options. Especially in the elderly current treatments show limited response or are associated with side effects. Injections with BTA are considered as a very safe treatment without lasting side effects. The aim of the study is to investigate effectiveness of BTA in treating major depression in the elderly in a cross-over designed, placebo-controlled manner.

Conditions

• Major Depressive Disorder
• Major Depressive Episode
• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	botulinum toxin A	glabellar injections with botulinum toxin A
DRUG	Placebos	glabellar injections with sodium chloride

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-12-31
• Completion: 2020-03-31
• First posted: 2019-02-06
• Last updated: 2021-08-11