Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

Study Overview
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Brief Summary
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The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.

Detailed Description
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Feedback from facial expressions is known to influence emotional experience. Treatment of muscles involved in facial expression of sadness, anger or anxiety with botulinumtoxin showed a quick, strong and sustained improvement in the symptoms of depression. As considerable proportion of patients do not sufficiently respond to existing treatment options. Especially in the elderly current treatments show limited response or are associated with side effects. Injections with BTA are considered as a very safe treatment without lasting side effects. The aim of the study is to investigate effectiveness of BTA in treating major depression in the elderly in a cross-over designed, placebo-controlled manner.

Official Title
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Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

Conditions
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Major Depressive Disorder, Major Depressive Episode, Treatment Resistant Depression

Intervention / Treatment
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* Drug: botulinum toxin A
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Clinically relevant depressive symptoms ( defined as MADRS > 12) Exclusion criteria: cognitive deficits that impair the participant´s ability to provide written informed consent severe depression MADRS >34 suicidality treatment with more than 3 psychotropic medications recent changes (4 weeks) in current psychotropic medication previous treatment with study drug active substance abuse bipolar disorder schizophrenia unstable medical condition usage of warfarin or NOAC bleeding disorder known hypersensitivity to study drog or any of the excipients of the formulation myasthenia gravis or Eaton Lambert syndrome presence of infection at the proposed injection sites

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 99 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: Crossover Assignment
Interventional Model Description: placebo controlled, randomized, cross-over
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>injections with sodium chloride | Drug: Placebos<br>* glabellar injections with sodium chloride<br>* Other names: sodium chloride;|
| Active Comparator: botulinum toxin A<br>injections with botulinum toxin A | Drug: botulinum toxin A<br>* glabellar injections with botulinum toxin A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity og depressive symptoms, response to treatment | Response to treatment, as defined as a 50% or greater decrease in Montgomery Aasberg Depression Rating Scale (MADRS) from baseline Montgomery-Åsberg Depression Rating Scale The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.[4] The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission | remission rate, as defined by a Montgomery Aasberg Depression Rating Scale MADRS score of 10 or lower | 16 weeks | 
| severity of depressive symptoms, self-rated Geriatric Depression Scale (GDS) | severity of depressive symptoms, self-rated Geriatric Depression Scale (GDS) In the Geriatric Depression Scale, questions are answered yes or no. A five-category response set is not utilized in order to ensure that the scale is simple enough to be used when testing ill or moderately cognitively impaired individuals, for whom a more complex set of answers may be confusing, or lead to inaccurate recording of responses. The scale consists of 30 yes/no questions. Each question is scored as either 0 or 1 points. The following general cutoff may be used to qualify the severity: normal 0-9, mild depressives 10-19, severe depressives 20-30. | 16 weeks | 
| quality of life, as assessed with QOL-AD | quality of life, as assessed with the questionnaire QOL-AD Use of the QOL-AD for measuring quality of life in people with dementia Scoring instructions for QOL-AD: Points are assigned to each item as follows:poor=1,fair=2,good=3,excellent=4. The total score is the sum of all 13 items. | 16 weeks | 
| safety/tolerability | Incidence of Treatment-Emergent Adverse Events, as assessed by number in registration of AE/SAE | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinumtoxin, botox, depression, geriatric depression, depression in older adults, depression in the elderly, old age depression