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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03833063
Other study ID # 2019BR
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date May 1, 2019
Est. completion date March 31, 2020

Study information

Verified date February 2019
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years to 99 Years
Eligibility 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

Study Design


Intervention

Drug:
botulinum toxin A
glabellar injections with botulinum toxin A
Placebos
glabellar injections with sodium chloride

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Helse Stavanger HF

Outcome

Type Measure Description Time frame Safety issue
Primary 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 remission remission rate, as defined by a Montgomery Aasberg Depression Rating Scale MADRS score of 10 or lower 16 weeks
Secondary 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
Secondary 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
Secondary safety/tolerability Incidence of Treatment-Emergent Adverse Events, as assessed by number in registration of AE/SAE 16 weeks
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