Botulinum Toxin for the Treatment of Depression

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Depression

Treatments: Other: 0.9% NaCl solution; Drug: clostridium botulinum toxin type A neurotoxin complex

Study type: Interventional

Funder types: Other

Identifiers

NCT00934687

EKBB14/09

2009DR2125

Details and patient eligibility

About

Depression is frequently accompanied by a specific sad facial expression. This expression is in part mediated by the same muscle activity that produces frown lines. Based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. The investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. This hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (Finzi and Wasserman, 2006).

Enrollment: 30 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate depression (Ham-D >=15)
• Therapy with one antidepressant for at least four weeks
• at least moderate frown line

Exclusion criteria

• Bipolar depression
• Psychiatric comorbidity
• Severe somatic comorbidity
• Pregnancy
• Peculiarities at the injection site
• Psychiatric medication other than one antidepressant
• Specific psychotherapy
• Previous application of botulinum toxin
• Medication interfering with botulinum toxin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

clostridium botulinum toxin type A neurotoxin complex

Experimental group

Description:

A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.

Treatment:

Drug: clostridium botulinum toxin type A neurotoxin complex

0.9% sodium chloride NaCl solution

Placebo Comparator group

Description:

0.9% NaCl solution will be injected like the experimental compound

Treatment:

Other: 0.9% NaCl solution