Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-03-31

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.

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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.

Conditions

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Major Depressive Disorder Major Depressive Episode Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

placebo controlled, randomized, cross-over

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

injections with sodium chloride

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

glabellar injections with sodium chloride

botulinum toxin A

injections with botulinum toxin A

Group Type ACTIVE_COMPARATOR

botulinum toxin A

Intervention Type DRUG

glabellar injections with botulinum toxin A

Interventions

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botulinum toxin A

glabellar injections with botulinum toxin A

Intervention Type DRUG

Placebos

glabellar injections with sodium chloride

Intervention Type DRUG

Other Intervention Names

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sodium chloride

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No