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| ID | Type | Description | Link |
|---|---|---|---|
| EKBB14/09 |
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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clostridium botulinum toxin type A neurotoxin complex | Experimental | 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. |
|
| 0.9% sodium chloride NaCl solution | Placebo Comparator | 0.9% NaCl solution will be injected like the experimental compound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clostridium botulinum toxin type A neurotoxin complex | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (reduction in Ham-D score by >30% compared to baseline) | six weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc A Wollmer, MD | Asklepios Klinik Nord - Ochsenzoll, Hamburg/D | Principal Investigator |
| Tillmann HC Krüger, MD | Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy | Hanover | 30625 | Germany | |||
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 0.9% NaCl solution | Other | 0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator. |
|
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| response by self rating (BDI) |
| six weeks |
| need for additional treatment | eight weeks, twelve weeks, or sixteen weeks |
| Psychiatry Hospital of the University of Basel, Basel, Switzerland |
| Basel |
| Basel Town |
| Switzerland |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |