Back to resultsGlabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression (BOTDEP)
Primary Purpose
Major Depressive Disorder, Major Depressive Episode, Treatment Resistant Depression
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
botulinum toxin A
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring botulinumtoxin, botox, depression, geriatric depression, depression in older adults, depression in the elderly, old age depression
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
botulinum toxin A
Arm Description
injections with sodium chloride
injections with botulinum toxin A
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
remission
remission rate, as defined by a Montgomery Aasberg Depression Rating Scale MADRS score of 10 or lower
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.
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.
safety/tolerability
Incidence of Treatment-Emergent Adverse Events, as assessed by number in registration of AE/SAE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03833063
Brief Title
Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Acronym
BOTDEP
Official Title
Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
recruitment difficulties due to COVID19
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Major Depressive Episode, Treatment Resistant Depression
Keywords
botulinumtoxin, botox, depression, geriatric depression, depression in older adults, depression in the elderly, old age depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
placebo controlled, randomized, cross-over
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
injections with sodium chloride
Arm Title
botulinum toxin A
Arm Type
Active Comparator
Arm Description
injections with botulinum toxin A
Intervention Type
Drug
Intervention Name(s)
botulinum toxin A
Intervention Description
glabellar injections with botulinum toxin A
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
sodium chloride
Intervention Description
glabellar injections with sodium chloride
Primary Outcome Measure Information:
Title
Severity og depressive symptoms, response to treatment
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
remission
Description
remission rate, as defined by a Montgomery Aasberg Depression Rating Scale MADRS score of 10 or lower
Time Frame
16 weeks
Title
severity of depressive symptoms, self-rated Geriatric Depression Scale (GDS)
Description
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.
Time Frame
16 weeks
Title
quality of life, as assessed with QOL-AD
Description
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.
Time Frame
16 weeks
Title
safety/tolerability
Description
Incidence of Treatment-Emergent Adverse Events, as assessed by number in registration of AE/SAE
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
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