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The Treatment of Depression With Botulinum Type A Toxin

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
botulinum toxin type A neurotoxin complex
Placebo
Sponsored by
Seton Healthcare Family
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring botox, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male/Female between the ages of 18 and 65

  2. Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms:

    • Significant weight loss or weight gain.
    • Insomnia or hypersomnia
    • Psychomotor agitation or retardation
    • Feelings of worthlessness or excessive guilt
    • Poor Concentration
    • Fatigue or loss of energy
    • Suicidal thoughts
  3. History of depression for at least 6 months
  4. Initial score 14 or higher on initial Hamilton Depression rating scale.
  5. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study

Exclusion Criteria:

  1. Active substance abuse
  2. Bipolar Depression
  3. Subjects who are pregnant, nursing or trying to become pregnant during study participation
  4. Subjects who are currently on more than 3 psychiatric medications at the time of enrollment
  5. Current medications used to treat depression must be stable for at least 60 days prior to enrollment
  6. Previous Botox treatment
  7. The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.

Sites / Locations

  • Seton Mind Institute: Medical Park Tower

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Botox, Then Placebo

Placebo, Then Botox

Arm Description

At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).

At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).

Outcomes

Primary Outcome Measures

Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6

Secondary Outcome Measures

Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score) Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.

Full Information

First Posted
July 8, 2011
Last Updated
July 23, 2018
Sponsor
Seton Healthcare Family
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1. Study Identification

Unique Protocol Identification Number
NCT01392963
Brief Title
The Treatment of Depression With Botulinum Type A Toxin
Official Title
The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seton Healthcare Family

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.
Detailed Description
Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
botox, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox, Then Placebo
Arm Type
Experimental
Arm Description
At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
Arm Title
Placebo, Then Botox
Arm Type
Experimental
Arm Description
At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
Intervention Type
Drug
Intervention Name(s)
botulinum toxin type A neurotoxin complex
Other Intervention Name(s)
Botox, botulinum toxin type A (BTA)
Intervention Description
29-40 U injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
botulinum toxin type A neurotoxin complex matched injection
Intervention Description
29-40 U 0.9% NaCl injection
Primary Outcome Measure Information:
Title
Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
Description
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6
Time Frame
baseline and week 6
Secondary Outcome Measure Information:
Title
Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)
Description
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score) Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.
Time Frame
Baseline (Week 0), Week 6, and Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/Female between the ages of 18 and 65 Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms: Significant weight loss or weight gain. Insomnia or hypersomnia Psychomotor agitation or retardation Feelings of worthlessness or excessive guilt Poor Concentration Fatigue or loss of energy Suicidal thoughts History of depression for at least 6 months Initial score 14 or higher on initial Hamilton Depression rating scale. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study Exclusion Criteria: Active substance abuse Bipolar Depression Subjects who are pregnant, nursing or trying to become pregnant during study participation Subjects who are currently on more than 3 psychiatric medications at the time of enrollment Current medications used to treat depression must be stable for at least 60 days prior to enrollment Previous Botox treatment The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Magid, MD
Organizational Affiliation
Seton Healthcare Family
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seton Mind Institute: Medical Park Tower
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24910934
Citation
Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Aug;75(8):837-44. doi: 10.4088/JCP.13m08845.
Results Reference
result
PubMed Identifier
35588104
Citation
Crowley JS, Silverstein ML, Reghunathan M, Gosman AA. Glabellar Botulinum Toxin Injection Improves Depression Scores: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2022 Jul 1;150(1):211e-220e. doi: 10.1097/PRS.0000000000009240. Epub 2022 May 20.
Results Reference
derived

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The Treatment of Depression With Botulinum Type A Toxin

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