Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression (BOTDEP)

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.

Study Overview

• Status: Withdrawn
• Conditions: Major Depressive Disorder; Treatment Resistant Depression; Major Depressive Episode
• Intervention / Treatment: Drug: Placebos; Drug: botulinum toxin A

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.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; injections with sodium chloride	Drug: Placebos; glabellar injections with sodium chloride; Other Names: sodium chloride
Active Comparator: botulinum toxin A; injections with botulinum toxin A	Drug: botulinum toxin A; glabellar injections with botulinum toxin A

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: depression; botox; depression in the elderly; geriatric depression; botulinumtoxin; depression in older adults; old age depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2019BR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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