Depression
Conditions
Keywords
depression, depressive, botulinum, botox
Brief summary
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).
Interventions
DRUGclostridium botulinum toxin type A neurotoxin complex
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.
OTHER0.9% NaCl solution
0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
Sponsors
Hannover Medical School
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (reduction in Ham-D score by >30% compared to baseline) | six weeks |
Secondary
| Measure | 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 |
Countries
Germany, Switzerland
Outcome results
None listed