Completed
PHASE2
INTERVENTIONAL
NCT01392963
The Treatment of Depression With Botulinum Type A Toxin
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Interventions
Name:
botulinum toxin type A neurotoxin complex
Type:
DRUG
Description:
29-40 U injection
Name:
Placebo
Type:
DRUG
Description:
29-40 U 0.9% NaCl injection
Primary Outcomes
Measure:
Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
TimeFrame:
baseline and week 6
Description:
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score).
PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6
Trial Information
NCT ID
NCT01392963
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Seton Healthcare Family
Last Updated
December 15, 2025