Botulinum Toxin for the Treatment of Depression

Study Overview
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Brief Summary
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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).

Official Title
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Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study

Conditions
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Depression

Intervention / Treatment
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* Drug: clostridium botulinum toxin type A neurotoxin complex
* Other: 0.9% NaCl solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clostridium botulinum toxin type A neurotoxin complex<br>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. | Drug: clostridium botulinum toxin type A neurotoxin complex<br>* 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.<br>* Other names: Botox;|
| Placebo Comparator: 0.9% sodium chloride NaCl solution<br>0.9% NaCl solution will be injected like the experimental compound | Other: 0.9% NaCl solution<br>* 0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.<br>* Other names: NaCl 0.9% B. Braun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (reduction in Ham-D score by >30% compared to baseline) |  | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (number of patients with HAM-D score < 8) |  | six weeks | 
| Time to response (20% reduction of HAM-D score compared to baseline) |  | two, four, or six weeks | 
| response by self rating (BDI) |  | six weeks | 
| need for additional treatment |  | eight weeks, twelve weeks, or sixteen weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, depressive, botulinum, botox