Status:
WITHDRAWN
Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Lead Sponsor:
Helse Stavanger HF
Conditions:
Major Depressive Disorder
Major Depressive Episode
Eligibility:
All Genders
65-99 years
Phase:
PHASE1
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 glabella...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03833063
Start Date
May 1 2019
End Date
March 31 2020
Last Update
August 11 2021
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